Medical device inserters and processes of inserting and using medical devices

ABSTRACT

An apparatus for insertion of a medical device in the skin of a subject is provided, as well as methods of inserting medical devices.

RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 18/114,775, filed Feb. 27, 2023, which is a continuation ofU.S. patent application Ser. No. 16/387,023, filed Apr. 17, 2019, nowabandoned, which is a continuation of U.S. patent application Ser. No.14/884,622, filed Oct. 15, 2015, now U.S. Pat. No. 10,292,632, which isa continuation of U.S. patent application Ser. No. 13/071,497, filedMar. 24, 2011, now U.S. Pat. No. 9,186,098, which claims the benefit ofU.S. Provisional Application Nos. 61/317,243, filed Mar. 24, 2010;61/345,562, filed May 17, 2010; 61/361,374, filed Jul. 2, 2010; and61/411,262, filed Nov. 8, 2010, all of which are incorporated herein byreference in their entireties and for all purposes.

INCORPORATION BY REFERENCE

Patents, applications and/or publications described herein, includingthe following patents, applications and/or publications are incorporatedherein by reference for all purposes: U.S. Pat. Nos. 4,545,382;4,711,245; 5,262,035; 5,262,305; 5,264,104; 5,320,715; 5,356,786;5,509,410; 5,543,326; 5,593,852; 5,601,435; 5,628,890; 5,820,551;5,822,715; 5,899,855; 5,918,603; 6,071,391; 6,103,033; 6,120,676;6,121,009; 6,134,461; 6,143,164; 6,144,837; 6,161,095; 6,175,752;6,270,455; 6,284,478; 6,299,757; 6,338,790; 6,377,894; 6,461,496;6,503,381; 6,514,460; 6,514,718; 6,540,891; 6,560,471; 6,579,690;6,591,125; 6,592,745; 6,600,997; 6,605,200; 6,605,201; 6,616,819;6,618,934; 6,650,471; 6,654,625; 6,676,816; 6,730,200; 6,736,957;6,746,582; 6,749,740; 6,764,581; 6,773,671; 6,881,551; 6,893,545;6,932,892; 6,932,894; 6,942,518; 7,041,468; 7,167,818; and 7,299,082;7,381,184; 7,740,581; 7,811,231 U.S. Published Application Nos.2005/0182306; 2006/0091006; 2007/0056858, now U.S. Pat. No. 8,298,389;2007/0068807, now U.S. Pat. No. 7,846,311; 2007/0095661; 2007/0108048,now U.S. Pat. No. 7,918,975; 2007/0149873; 2007/0149875, now U.S. Pat.No. 8,515,518; 2007/0199818, now U.S. Pat. No. 7,811,430; 2007/0227911,now U.S. Pat. No. 7,887,682; 2007/0233013; 2008/0058625, now U.S. Pat.No. 7,920,907; 2008/0064937; 2008/0066305, now U.S. Pat. No. 7,895,740;2008/0071157; 2008/0071158; 2008/0081977, now U.S. Pat. No. 7,618,369;2008/0102441, now U.S. Pat. No. 7,822,557; 2008/0148873, now U.S. Pat.No. 7,802,467; 2008/0161666; 2008/0179187; 2008/0267823; 2008/0319295,now U.S. Pat. No. 8,597,188; 2008/0319296, now U.S. Pat. No. 8,617,069;2009/0018425, now U.S. Pat. No. 8,160,670; 2009/0247857, now U.S. Pat.No. 8,346,335; 2009/0257911, now U.S. Pat. No. 8,252,229, 2009/0281406;2009/0294277; 2009/0054748, now U.S. Pat. No. 7,885,698; 2009/0054749;2010/0030052; 2010/0065441, now U.S. Pat. No. 8,636,884; 2010/0081905;2010/0081909, now U.S. Pat. No. 8,219,173; 2010/0213057; 2010/0325868,now U.S. Pat. No. 7,866,026; 2010/0326842; 2010/0326843, now U.S. Pat.No. 8,437,827; 2010/0331643; 2011/0046466; U.S. patent application Ser.Nos. 12/624,767; 12/625,185, now U.S. Pat. No. 8,354,013; Ser. Nos.12/625,208; 12/625,524, now U.S. Pat. No. 8,390,455; Ser. No.12/625,525, now U.S. Pat. No. 8,358,210; Ser. No. 12/625,528, now U.S.Pat. No. 8,115,635; Ser. Nos. 12/628,177; 12/628,198; 12/628,201;12/628,203; 12/628,210; 12/698,124; 12/698,129; 12/699,653; 12/699,844;12/714,439; 12/730,193; 12/794,721, now U.S. Pat. No. 8,595,607; Ser.Nos. 12/807,278; 12/842,013; 12/870,818; 12/871,901, now U.S. Pat. No.8,514,086; Ser. Nos. 12/873,301; 12/873,302; 13/011,897; and U.S.Provisional Application Nos. 61/238,646; 61/246,825; 61/247,516;61/249,535; 61/317,243; 61/325,155; 61/345,562; and 61/359,265.

BACKGROUND OF THE INVENTION

The detection and/or monitoring of glucose levels or other analytes,such as lactate, oxygen, A1C, or the like, in certain individuals isvitally important to their health. For example, the monitoring ofglucose is particularly important to individuals with diabetes.Diabetics generally monitor glucose levels to determine if their glucoselevels are being maintained within a clinically safe range, and may alsouse this information to determine if and/or when insulin is needed toreduce glucose levels in their bodies or when additional glucose isneeded to raise the level of glucose in their bodies.

Growing clinical data demonstrates a strong correlation between thefrequency of glucose monitoring and glycemic control. Despite suchcorrelation, many individuals diagnosed with a diabetic condition do notmonitor their glucose levels as frequently as they should due to acombination of factors including convenience, testing discretion, painassociated with glucose testing, and cost.

Devices have been developed for the automatic monitoring of analyte(s),such as glucose, in bodily fluid such as in the blood stream or ininterstitial fluid (“ISF”), or other biological fluid. Some of theseanalyte measuring devices are configured so that at least a portion ofthe devices are positioned below a skin surface of a user, e.g., in ablood vessel or in the subcutaneous tissue of a user, so that themonitoring is accomplished in vivo.

With the continued development of analyte monitoring devices andsystems, there is a need for such analyte monitoring devices, systems,and methods, as well as for processes for manufacturing analytemonitoring devices and systems that are cost effective, convenient, andwith reduced pain, provide discreet monitoring to encourage frequentanalyte monitoring to improve glycemic control.

SUMMARY

An apparatus for inserting a medical device through the skin of asubject is provided, which includes a housing defining a longitudinalcavity therein and a interference member extending into the cavity; abiasing member; a driver member coupled to the biasing member formovement from a proximal position to a distal position and furtherconfigured for movement between a misaligned configuration in which thedriver member is impeded from distal movement by the interference memberand an aligned configuration in which the driver member is not impededfrom distal movement by the interference member; and an actuator havingan alignment surface for moving the driver member from the misalignedconfiguration to the aligned configuration.

In some embodiments, the actuator is movable from a proximal position toa distal position. In some embodiments, distal movement of the actuatorcompresses the first biasing member. In some embodiments, the firstposition of the driver member is at an oblique angle with respect to thelongitudinal cavity. In some embodiments, the second position of thedriver member includes a configuration substantially aligned with thelongitudinal cavity.

An apparatus for inserting a medical device through the skin of asubject is provided, which includes a housing defining a cantilevermember; a sharp movable within the housing from a retracted position toa partially exposed position; and an electrochemical sensor releasablycoupled to the sharp for movement with the sharp, and for subsequentinsertion in the skin of a subject; wherein the cantilever memberresiliently contacts at least one of the sharp and the sensor.

In some embodiments, the housing includes a distal opening for releaseof the electrochemical sensor therefrom. In some embodiments, thehousing defines a longitudinal notch for reception of a drive member ofan inserter. In some embodiments, the housing contains a desiccant. Insome embodiments, the housing defines one or more longitudinal ridgesfor aligning one of the sharp and the sensor.

These and other features, objects, and advantages of the disclosedsubject matter will become apparent to those persons skilled in the artupon reading the detailed description as more fully described below.

BRIEF DESCRIPTION OF THE DRAWINGS

A detailed description of various aspects, features, and embodiments ofthe subject matter described herein is provided with reference to theaccompanying drawings, which are briefly described below. The drawingsare illustrative and are not necessarily drawn to scale, with somecomponents and features being exaggerated for clarity. The drawingsillustrate various aspects and features of the present subject matterand may illustrate one or more embodiment(s) or example(s) of thepresent subject matter in whole or in part.

FIG. 1 illustrates an analyte monitoring system for real time analyte(e.g., glucose) measurement, data acquisition and/or processing incertain embodiments;

FIGS. 2-3 are views of an electrochemical sensor in accordance with afurther embodiment of the disclosed subject matter;

FIGS. 4-5 are schematic views of a needle hub in accordance with oneembodiment of the disclosed subject matter;

FIG. 6 is a distal end view of a sharp in accordance with one embodimentof the disclosed subject matter;

FIG. 7 is a side view of a sharp in accordance with one embodiment ofthe disclosed subject matter;

FIG. 8 is a side view of a sharp in accordance with one embodiment ofthe disclosed subject matter;

FIG. 9 is a perspective view of a sharp in accordance with oneembodiment of the disclosed subject matter;

FIG. 10 is a schematic view of an alternate embodiment for forming asharp to be used in an inserter in accordance with one embodiment of thedisclosed subject matter;

FIG. 11 is a perspective view of an inserter in accordance with oneembodiment of the disclosed subject matter;

FIG. 12 is a perspective view with parts separated of an inserter inaccordance with one embodiment of the disclosed subject matter;

FIG. 13 is an enlarged sectional view with parts separated of aninserter in accordance with one embodiment of the disclosed subjectmatter;

FIG. 14 is a side view of another inserter in accordance with thedisclosed subject matter;

FIGS. 15-17 are sectional, perspective views of the inserter of FIG. 14in accordance with another embodiment of the disclosed subject matter;

FIG. 18 is a perspective view of another inserter in accordance with thedisclosed subject matter;

FIGS. 19-21 are side views with transparency of the inserter of FIG. 18in accordance with another embodiment of the disclosed subject matter;

FIG. 22 is a perspective view of another inserter in accordance with thedisclosed subject matter;

FIGS. 23-25 are sectional, perspective views of the inserter of FIG. 22in accordance with another embodiment of the disclosed subject matter;

FIG. 26 is a sectional view in section of another embodiment of aninserter in accordance with the disclosed subject matter;

FIG. 27 is a perspective view of the inserter of FIG. 26 in accordancewith the disclosed subject matter;

FIGS. 28-31 are perspective views of components of the inserter of FIG.26 in accordance with the disclosed subject matter;

FIG. 32 illustrates an exploded view of the inserter of FIG. 26 inaccordance with the disclosed subject matter;

FIG. 33 is a side view of the inserter of FIG. 26 in accordance with thedisclosed subject matter;

FIGS. 34-36 are side views with transparency of the inserter of FIG. 26in accordance with the disclosed subject matter;

FIG. 37 is an inserter in accordance with another embodiment inaccordance with the disclosed subject matter;

FIG. 38 is a perspective view in section of the inserter of FIG. 37 inaccordance with the disclosed subject matter;

FIG. 39 is a cross-sectional view of the inserter of FIG. 37 inaccordance with the disclosed subject matter;

FIG. 40 is a side view of the inserter of FIG. 37 in accordance with thedisclosed subject matter;

FIGS. 41-44 are perspective views of components of the inserter of FIG.37 in accordance with the disclosed subject matter;

FIG. 45 is an exploded view of the inserter of FIG. 37 in accordancewith the disclosed subject matter;

FIG. 46 is a side view with transparency of the inserter of FIG. 37 inaccordance with the disclosed subject matter;

FIGS. 47-51 are perspective views of another inserter in accordance withthe disclosed subject matter;

FIG. 52 is an exploded perspective view of another embodiment of thedisclosed subject matter;

FIG. 53 is a sectional view of an inserter in accordance with thedisclosed subject matter;

FIGS. 54-55 are perspective views from below of the inserter of FIG. 53;

FIG. 56 is a perspective view of another inserter in accordance with thedisclosed subject matter;

FIGS. 57-60 are perspective views of various components of the inserterof FIG. 56 ;

FIG. 61-62 are perspective views of various components of the inserterof FIG. 56 ;

FIGS. 63-65 depict different subassemblies of the components of theinserter of FIG. 56 ;

FIGS. 66-67 are cross-sectional views of a subassembly of the componentsof the inserter of FIG. 56 ;

FIGS. 68-70 depict the steps used to actuate the inserter of FIG. 56 ;

FIG. 71 is a perspective view of an inserter assembly in accordance withthe disclosed subject matter;

FIG. 72 is a perspective view of a component of an inserter assembly ofFIG. 71 in accordance with the disclosed subject matter;

FIG. 73 is a perspective view of a component of an analyte measurementsystem in accordance with the disclosed subject matter;

FIG. 74 is a perspective view with parts separated of the inserterassembly of FIG. 71 in accordance with the disclosed subject matter;

FIG. 75 is a cross-sectional view of the inserter assembly of FIG. 71 inaccordance with the disclosed subject matter;

FIG. 76 is a side view of a portion of an inserter assembly inaccordance with the disclosed subject matter;

FIG. 77 is a view of an analyte sensor in accordance with the disclosedsubject matter;

FIGS. 78-79 are perspective views of a portion of an inserter assemblyin accordance with the disclosed subject matter;

FIGS. 80-90 are views of analyte sensors in accordance with thedisclosed subject matter;

FIGS. 91-92 are cross-sectional views of an inserter assembly inaccordance with the disclosed subject matter;

FIGS. 93-94 are cross-sectional views of another inserter assembly inaccordance with the disclosed subject matter;

FIGS. 95-96 are cross-sectional views of a further inserter assembly inaccordance with the disclosed subject matter;

FIGS. 97-98 are views of a portion of an inserter assembly in accordancewith the disclosed subject matter;

FIG. 99 is a cross-sectional view of a portion of an inserter assemblyin accordance with the disclosed subject matter;

FIGS. 100-101 are perspective views of a portion of an inserter assemblyin accordance with the disclosed subject matter;

FIGS. 102-105 are side views of various inserter assemblies inaccordance with the disclosed subject matter;

FIGS. 106-112 are views of a sharp and sharp carrier in accordance withthe disclosed subject matter;

FIG. 113 is a perspective view of a portion of an inserter assembly inaccordance with the disclosed subject matter;

FIGS. 114-117 are perspective views illustrating the operation of aninserter assembly in accordance with the disclosed subject matter;

FIG. 118 is a side view of an inserter assembly in accordance with thedisclosed subject matter;

FIGS. 119-121 are cross-sectional views of an inserter assembly inaccordance with the disclosed subject matter;

FIG. 122 is a perspective view with parts separated of an embodiment ofa sharp/sensor cartridge in accordance with the disclosed subjectmatter;

FIG. 123 is a perspective view of the cartridge of FIG. 122 in a firststage of deployment in accordance with the disclosed subject matter;

FIG. 124 is a cross-sectional view of the cartridge of FIG. 122 in aneutral state in accordance with the disclosed subject matter;

FIG. 125 is a perspective view of the cartridge of FIG. 122 in a neutralstate in accordance with the disclosed subject matter;

FIG. 126 is a cross-sectional view of the cartridge of FIG. 122 in afirst stage of deployment in accordance with the disclosed subjectmatter;

FIG. 127 is a perspective view of the cartridge of FIG. 122 in a secondstage of deployment in accordance with the disclosed subject matter;

FIG. 128 is a cross-sectional view of the cartridge of FIG. 122 in asecond stage of deployment in accordance with the disclosed subjectmatter;

FIG. 129 is a perspective view of the cartridge of FIG. 122 in a thirdstage of deployment in accordance with the disclosed subject matter;

FIG. 130 is a cross-sectional view of the cartridge of FIG. 122 in athird stage of deployment in accordance with the disclosed subjectmatter;

FIG. 131 is a perspective view with parts separated of anotherembodiment of a component of an inserter in accordance with thedisclosed subject matter;

FIG. 132 is a perspective view of the cartridge of FIG. 131 in a neutralstate in accordance with the disclosed subject matter;

FIG. 133 is a cross-sectional view of the cartridge of FIG. 131 in aneutral state in accordance with the disclosed subject matter;

FIG. 134 is a perspective view of the cartridge of FIG. 131 in a secondstage of deployment in accordance with the disclosed subject matter;

FIG. 135 is a cross-sectional view of the cartridge of FIG. 131 in asecond stage of deployment in accordance with the disclosed subjectmatter;

FIG. 136 is a perspective view of the cartridge of FIG. 131 in a thirdstage of deployment in accordance with the disclosed subject matter; and

FIG. 137 is a cross-sectional view of the cartridge of FIG. 131 in athird stage of deployment in accordance with the disclosed subjectmatter.

DETAILED DESCRIPTION OF THE EMBODIMENTS

A detailed description of the disclosure is provided herein. It shouldbe understood, in connection with the following description, that thesubject matter is not limited to particular embodiments described, asthe particular embodiments of the subject matter may, of course, vary.It is also to be understood that the terminology used herein is for thepurpose of describing particular embodiments only, and is not intendedto be limiting, since the scope of the disclosed subject matter will belimited only by the appended claims.

Where a range of values is provided, it is understood that eachintervening value between the upper and lower limit of that range, andany other stated or intervening value in that stated range, isencompassed within the disclosed subject matter. Every range stated isalso intended to specifically disclose each and every “subrange” of thestated range. That is, each and every range smaller than the outsiderange specified by the outside upper and outside lower limits given fora range, whose upper and lower limits are within the range from saidoutside lower limit to said outside upper limit (unless the contextclearly dictates otherwise), is also to be understood as encompassedwithin the disclosed subject matter, subject to any specificallyexcluded range or limit within the stated range. Where a range is statedby specifying one or both of an upper and lower limit, ranges excludingeither or both of those stated limits, or including one or both of them,are also encompassed within the disclosed subject matter, regardless ofwhether or not words such as “from,” “to,” “through,” or “including” areor are not used in describing the range.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosed subject matter belongs. Although anymethods and materials similar or equivalent to those described hereincan also be used in the practice or testing of the present disclosedsubject matter, this disclosure may specifically mention certainexemplary methods and materials.

All publications mentioned in this disclosure are, unless otherwisespecified, incorporated by reference herein for all purposes, includingwithout limitation to disclose and describe the methods and/or materialsin connection with which the publications are cited.

The publications discussed herein are provided solely for theirdisclosure prior to the filing date of the present application. Nothingherein is to be construed as an admission that the present disclosedsubject matter is not entitled to antedate such publication by virtue ofprior invention. Further, the dates of publication provided may bedifferent from the actual publication dates, which may need to beindependently confirmed.

As used herein and in the appended claims, the singular forms “a,” “an,”and “the” include plural referents unless the context clearly dictatesotherwise.

Nothing contained in the Abstract or the Summary should be understood aslimiting the scope of the disclosure. The Abstract and the Summary areprovided for bibliographic and convenience purposes and due to theirformats and purposes should not be considered comprehensive.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual embodiments described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalembodiments without departing from the scope or spirit of the presentdisclosed subject matter. Any recited method can be carried out in theorder of events recited, or in any other order which is logicallypossible.

Reference to a singular item includes the possibility that there areplural of the same item present. When two or more items (for example,elements or processes) are referenced by an alternative “or,” thisindicates that either could be present separately or any combination ofthem could be present together except where the presence of onenecessarily excludes the other or others.

Generally, embodiments of the present disclosure relate to an apparatusfor inserting a medical device at least partially into the skin of thepatient. Some embodiments relate to in vivo methods and devices fordetecting at least one analyte such as glucose in body fluid.Accordingly, embodiments include in vivo analyte sensors configured sothat at least a portion of the sensor is positioned in the body of auser (e.g., within the ISF), to obtain information about at least oneanalyte of the body, e.g., transcutaneously positioned in user's body.In certain embodiments, an in vivo analyte sensor is coupled to anelectronics unit that is maintained on the body of the user to processinformation obtained from the sensor.

In certain embodiments, analyte information is communicated from a firstdevice such as an on body electronics unit to a second device which mayinclude user interface features, including a display, and/or the like.Information may be communicated from the first device to the seconddevice automatically and/or continuously when the analyte information isavailable, or may not be communicated automatically and/or continuously,but rather stored or logged in a memory of the first device.Accordingly, in many embodiments of the system, analyte informationderived by the sensor/on body electronics (for example, on bodyelectronics) is made available in a user-usable or viewable form onlywhen queried by the user such that the timing of data communication isselected by the user. In some embodiments, the display of information isselected by the user, while the timing of data communication is not.

In this manner, analyte information is only provided or evident to auser (provided at a user interface device) in some embodiments whendesired by the user even though an in vivo analyte sensor automaticallyand/or continuously monitors the analyte level in vivo, i.e., the sensorautomatically monitors analyte such as glucose on a pre-defined timeinterval over its usage life. For example, an analyte sensor may bepositioned in vivo and coupled to on body electronics for a givensensing period, e.g., about 14 days. In certain embodiments, thesensor-derived analyte information is automatically communicated fromthe sensor electronics assembly to a remote monitor device or displaydevice for output to a user throughout the 14 day period according to aschedule programmed at the on body electronics (e.g., about every 1minute or about every 5 minutes or about every 10 minutes, or the like).In certain embodiments, sensor-derived analyte information is onlycommunicated from the sensor electronics assembly to a remote monitordevice or display device at user-determined times, e.g., whenever a userdecides to check analyte information. At such times, a communicationssystem is activated, and sensor-derived information is then sent fromthe on body electronics to the remote device or display device.

In still other embodiments, the information may be communicated from thefirst device to the second device automatically and/or continuously whenthe analyte information is available, and the second device stores orlogs the received information without presenting or outputting theinformation to the user. In such embodiments, the information isreceived by the second device from the first device when the informationbecomes available (e.g., when the sensor detects the analyte levelaccording to a time schedule). However, the received information isinitially stored in the second device and only output to a userinterface or an output component of the second device (e.g., display)upon detection of a request for the information on the second device.

Accordingly, in certain embodiments an inserter as described herein isused to place a sensor electronics assembly on the body so that at leasta portion of the in vivo sensor is in contact with bodily fluid such asISF. Once the sensor is electrically coupled to the electronics unit,sensor derived analyte information may be communicated from the on bodyelectronics to a display device on-demand by powering on the displaydevice (or it may be continually powered), and executing a softwarealgorithm stored in and accessed from a memory of the display device, togenerate one or more request commands, control signal or data packet tosend to the on body electronics. The software algorithm executed under,for example, the control of the microprocessor or application specificintegrated circuit (ASIC) of the display device may include routines todetect the position of the on body electronics relative to the displaydevice to initiate the transmission of the generated request command,control signal and/or data packet.

Display devices may also include programming stored in memory forexecution by one or more microprocessors and/or ASICs to generate andtransmit the one or more request command, control signal or data packetto send to the on body electronics in response to a user activation ofan input mechanism on the display device such as depressing a button onthe display device, triggering a soft button associated with the datacommunication function, and so on. The input mechanism may bealternatively or additionally provided on or in the on body electronicswhich may be configured for user activation. In certain embodiments,voice commands or audible signals may be used to prompt or instruct themicroprocessor or ASIC to execute the software routine(s) stored in thememory to generate and transmit the one or more request command, controlsignal or data packet to the on body device. In the embodiments that arevoice activated or responsive to voice commands or audible signals, onbody electronics and/or display device includes a microphone, a speaker,and processing routines stored in the respective memories of the on bodyelectronics and/or the display device to process the voice commandsand/or audible signals. In certain embodiments, positioning the on bodyelectronics and the display device within a predetermined distance(e.g., close proximity) relative to each other initiates one or moresoftware routines stored in the memory of the display device to generateand transmit a request command, control signal or data packet.

Different types and/or forms and/or amounts of information may be sentfor each on demand reading, including but not limited to one or more ofcurrent analyte level information (i.e., real time or the most recentlyobtained analyte level information temporally corresponding to the timethe reading is initiated), rate of change of an analyte over apredetermined time period, rate of the rate of change of an analyte(acceleration in the rate of change), historical analyte informationcorresponding to analyte information obtained prior to a given readingand stored in memory of the assembly. Some or all of real time,historical, rate of change, rate of rate of change (such as accelerationor deceleration) information may be sent to a display device for a givenreading. In certain embodiments, the type and/or form and/or amount ofinformation sent to a display device may be preprogrammed and/orunchangeable (e.g., preset at manufacturing), or may not bepreprogrammed and/or unchangeable so that it may be selectable and/orchangeable in the field one or more times (e.g., by activating a switchof the system, etc.). Accordingly, in certain embodiments, for each ondemand reading, a display device will output a current (real time)sensor-derived analyte value (e.g., in numerical format), a current rateof analyte change (e.g., in the form of an analyte rate indicator suchas an arrow pointing in a direction to indicate the current rate), andanalyte trend history data based on sensor readings acquired by andstored in memory of on body electronics (e.g., in the form of agraphical trace). Additionally, the on skin or sensor temperaturereading or measurement associated with each on demand reading may becommunicated from the on body electronics to the display device. Thetemperature reading or measurement, however, may not be output ordisplayed on the display device, but rather, used in conjunction with asoftware routine executed by the display device to correct or compensatethe analyte measurement output to the user on the display device.

As described, embodiments include inserters for in vivo analyte sensorsand on body electronics that together provide body wearable sensorelectronics assemblies. In certain embodiments, in vivo analyte sensorsare fully integrated with on body electronics (fixedly connected duringmanufacture), while in other embodiments they are separate butconnectable post manufacture (e.g., before, during or after sensorinsertion into a body). On body electronics may include an in vivoglucose sensor, electronics, battery, and antenna encased (except forthe sensor portion that is for in vivo positioning) in a waterproofhousing that includes or is attachable to an adhesive pad. In certainembodiments, the housing withstands immersion in about one meter ofwater for up to at least 30 minutes. In certain embodiments, the housingwithstands continuous underwater contact, e.g., for longer than about 30minutes, and continues to function properly according to its intendeduse, e.g., without water damage to the housing electronics where thehousing is suitable for water submersion.

Embodiments include sensor insertion devices, which also may be referredto herein as sensor delivery units, or the like. Insertion devices mayretain on body electronics assemblies completely in an interiorcompartment, i.e., an insertion device may be “pre-loaded” with on bodyelectronics assemblies during the manufacturing process (e.g., on bodyelectronics may be packaged in a sterile interior compartment of aninsertion device). In such embodiments, insertion devices may formsensor assembly packages (including sterile packages) for pre-use or newon body electronics assemblies, and insertion devices configured toapply on body electronics assemblies to recipient bodies.

Embodiments include portable handheld display devices, as separatedevices and spaced apart from an on body electronics assembly, thatcollect information from the assemblies and provide sensor derivedanalyte readings to users. Such devices may also be referred to asmeters, readers, monitors, receivers, human interface devices,companions, or the like. Certain embodiments may include an integratedin vitro analyte meter. In certain embodiments, display devices includeone or more wired or wireless communications ports such as USB, serial,parallel, or the like, configured to establish communication between adisplay device and another unit (e.g., on body electronics, power unitto recharge a battery, a PC, etc.). For example, a display devicecommunication port may enable charging a display device battery with arespective charging cable and/or data exchange between a display deviceand its compatible informatics software.

Compatible informatics software in certain embodiments include, forexample, but not limited to stand alone or network connection enableddata management software program, resident or running on a displaydevice, personal computer, a server terminal, for example, to performdata analysis, charting, data storage, data archiving and datacommunication as well as data synchronization. Informatics software incertain embodiments may also include software for executing fieldupgradable functions to upgrade firmware of a display device and/or onbody electronics unit to upgrade the resident software on the displaydevice and/or the on body electronics unit, e.g., with versions offirmware that include additional features and/or include software bugsor errors fixed, etc. Embodiments may include a haptic feedback featuresuch as a vibration motor or the like, configured so that correspondingnotifications (e.g., a successful on-demand reading received at adisplay device), may be delivered in the form of haptic feedback.

Embodiments include programming embedded on a computer readable medium,i.e., computer-based application software (may also be referred toherein as informatics software or programming or the like) thatprocesses analyte information obtained from the system and/or userself-reported data. Application software may be installed on a hostcomputer such as a mobile telephone, PC, an Internet-enabled humaninterface device such as an Internet-enabled phone, personal digitalassistant, or the like, by a display device or an on body electronicsunit. Informatics programming may transform data acquired and stored ona display device or on body unit for use by a user.

Embodiments of the subject disclosure are described primarily withrespect to glucose monitoring devices and systems, and methods ofglucose monitoring, for convenience only and such description is in noway intended to limit the scope of the disclosure. It is to beunderstood that the analyte monitoring system may be configured tomonitor a variety of analytes at the same time or at different times.

As described in detail below, embodiments include devices, systems, kitsand/or methods to monitor one or more physiological parameters such as,for example, but not limited to, analyte levels, temperature levels,heart rate, user activity level, over a predetermined monitoring timeperiod. Also provided are methods of manufacturing. Predeterminedmonitoring time periods may be less than about 1 hour, or may includeabout 1 hour or more, e.g., about a few hours or more, e.g., about a fewdays of more, e.g., about 3 or more days, e.g., about 5 days or more,e.g., about 7 days or more, e.g., about 10 days or more, e.g., about 14days or more, e.g., about several weeks, e.g., about 1 month or more. Incertain embodiments, after the expiration of the predeterminedmonitoring time period, one or more features of the system may beautomatically deactivated or disabled at the on body electronicsassembly and/or display device.

For example, a predetermined monitoring time period may begin withpositioning the sensor in vivo and in contact with a body fluid such asISF, and/or with the initiation (or powering on to full operationalmode) of the on body electronics. Initialization of on body electronicsmay be implemented with a command generated and transmitted by a displaydevice in response to the activation of a switch and/or by placing thedisplay device within a predetermined distance (e.g., close proximity)to the on body electronics, or by user manual activation of a switch onthe on body electronics unit, e.g., depressing a button, or suchactivation may be caused by the insertion device, e.g., as described inU.S. patent application Ser. No. 12/698,129 filed on Feb. 1, 2010 andU.S. Provisional Application Nos. 61/238,646, 61/246,825, 61/247,516,61/249,535, 61/317,243, 61/345,562, and 61/361,374, the disclosures ofeach of which are incorporated herein by reference for all purposes.

When initialized in response to a received command from a displaydevice, the on body electronics retrieves and executes from its memorysoftware routine to fully power on the components of the on bodyelectronics, effectively placing the on body electronics in fulloperational mode in response to receiving the activation command fromthe display device. For example, prior to the receipt of the commandfrom the display device, a portion of the components in the on bodyelectronics may be powered by its internal power supply such as abattery while another portion of the components in the on bodyelectronics may be in powered down or maintained in a low power stateincluding no power state, inactive mode, or all components may be in aninactive, powered down mode. Upon receipt of the command, the remainingportion (or all) of the components of the on body electronics isswitched to active, fully operational mode.

Embodiments of on body electronics may include one or more printedcircuit boards with electronics including control logic implemented inASIC, microprocessors, memory, and the like, and transcutaneouslypositionable analyte sensors forming a single assembly. On bodyelectronics may be configured to provide one or more signals or datapackets associated with a monitored analyte level upon detection of adisplay device of the analyte monitoring system within a predeterminedproximity for a period of time (for example, about 2 minutes, e.g., 1minute or less, e.g., about 30 seconds or less, e.g., about 10 secondsor less, e.g., about 5 seconds or less, e.g., about 2 seconds or less)and/or until a confirmation, such as an audible and/or visual and/ortactile (e.g., vibratory) notification, is output on the display deviceindicating successful acquisition of the analyte related signal from theon body electronics. A distinguishing notification may also be outputfor unsuccessful acquisition in certain embodiments.

In certain embodiments, the monitored analyte level may be correlatedand/or converted to glucose levels in blood or other fluids such as ISF.Such conversion may be accomplished with the on body electronics, but inmany embodiments will be accomplished with display device electronics.In certain embodiments, glucose level is derived from the monitoredanalyte level in the ISF.

Analyte sensors may be insertable into a vein, artery, or other portionof the body containing analyte. In certain embodiments, analyte sensorsmay be positioned in contact with ISF to detect the level of analyte,where the detected analyte level may be used to infer the user's glucoselevel in blood or interstitial tissue.

Embodiments include transcutaneous sensors and also wholly implantablesensors and wholly implantable assemblies in which a single assemblyincluding the analyte sensor and electronics are provided in a sealedhousing (e.g., hermetically sealed biocompatible housing) forimplantation in a user's body for monitoring one or more physiologicalparameters.

Embodiments include analyte monitors that are provided in small,lightweight, battery-powered and electronically-controlled systems. Suchsystems may be configured to detect physical parameters of subjects,such as signals indicative of in vivo analyte levels using anelectrochemical sensor, and collect such signals, with or withoutprocessing. Any suitable measurement technique may be used to obtainsignals from the sensors, e.g., may detect current, may employpotentiometry, etc. Techniques may include, but are not limited toamperometry, coulometry, and voltammetry. In some embodiments, sensingsystems may be optical, colorimetric, and the like. In some embodiments,the portion of the system that performs this initial processing may beconfigured to provide the raw or at least initially processed data toanother unit for further collection and/or processing. Such provision ofdata may be affected, for example, by a wired connection, such as anelectrical, or by a wireless connection, such as an IR or RF connection.

In certain systems, the analyte sensor is in communication with on bodyelectronics. The on-body unit may include a housing in which the on bodyelectronics and at least a portion of the sensor are received.

Certain embodiments are modular. The on-body unit may be separatelyprovided as a physically distinct assembly from a monitor unit, e.g.,which displays or otherwise indicates analyte levels to a user. Theon-body unit may be configured to provide the analyte levels detected bythe sensor and/or other information (such as temperature, sensor life,etc.) over a communication link to the monitor unit. The monitor unit,in some embodiments, may include, e.g., a mobile telephone device, an invitro glucose meter, a personal digital assistant, or other consumerelectronics such as MP3 device, camera, radio, personal computer, etc.,or other communication-enabled data-processing device.

The display unit may perform a variety of functions such as but notlimited to data storage and/or processing and/or analysis and/orcommunication, etc., on the received analyte data to generateinformation pertaining to the monitored analyte levels and/or processthe other information. The monitor unit may incorporate a displayscreen, which can be used, for example, to display measured analytelevels, and/or an audio component such as a speaker to audibly provideinformation to a user, and/or a vibration device to provide tactilefeedback to a user. It is also useful for a user of ananalyte-monitoring system to be able to see trend indications (includingthe magnitude and direction of any ongoing trend, e.g., the rate ofchange of an analyte or other parameter, and the amount of time asubject is above and/or below a threshold, such as a hypoglycemic and/orhyperglycemic threshold, etc.); such data may be displayed eithernumerically, or by a visual indicator such as an arrow that may vary invisual attributes, like size, shape, color, animation, or direction. Themonitor unit may further be adapted to receive information from or aboutan in vitro analyte test strip, which may be manually or automaticallyentered into the monitor unit. In some embodiments, a monitor unit mayincorporate an in vitro analyte test strip port and related electronicsin order to be able to make discrete (e.g., blood glucose) measurementsusing an in vitro test strip (see, e.g., U.S. Pat. No. 6,175,752, thedisclosure of which is incorporated by reference herein for allpurposes).

The modularity of these systems may vary where one or more componentsmay be constructed to be single use and one or more may be constructedto be re-useable. In some embodiments, the sensor is designed to beattachable and detachable from the on body electronics (and the on-bodyunit may be reusable), e.g., so that one or more of the components maybe reused one or more times, while in other embodiments, the sensor andon body electronics may be provided as an integrated, undetachablepackage, which may be designed to be disposable after use, i.e., notre-used.

Embodiments of In Vivo Monitoring Systems

For purpose of illustration, and not limitation, the inserters describedherein may be used in connection with an exemplary analyte monitoringsystem as depicted in FIG. 1 . It is understood that the insertersdescribed herein may be used with any medical device on its own or inconnection with a system. FIG. 1 shows an exemplary in vivo-basedanalyte monitoring system 100 in accordance with embodiments of thepresent disclosure. As shown, in certain embodiments, analyte monitoringsystem 100 includes on body electronics 1100 electrically coupled to invivo analyte sensor 14 (a proximal portion of which is shown in FIG. 1), and attached to adhesive layer 218 for attachment on a skin surfaceon the body of a user. On body electronics 1100 includes on body housing122 that defines an interior compartment.

Also shown in FIG. 1 is insertion device 200 (or insertion devices 300,400, 2400, 2500, 2700, 3700 described herein) that, when operated,transcutaneously positions a portion of analyte sensor 14 through a skinsurface and in fluid contact with ISF, and positions on body electronics1100 and adhesive layer 218 on a skin surface, as will be described ingreater detail herein. In certain embodiments, on body electronics 1100,analyte sensor 14 and adhesive layer 218 are sealed within the housingof insertion device 200 before use, and in certain embodiments, adhesivelayer 218 is also sealed within the housing or the adhesive layer canprovide a seal for preserving the sterility of the apparatus. Additionaldetails regarding insertion devices are discussed, e.g., in U.S. patentapplication Ser. No. 12/698,129 and U.S. Provisional Application Nos.61/238,646, 61/246,825, 61/247,516, 61/249,535, and 61/345,562, thedisclosures of each of which are incorporated herein by reference forall purposes.

Referring back to the FIG. 1 , analyte monitoring system 100 includesdisplay device 1200 which includes a display 1220 to output informationto the user, an input component 1210 such as a button, actuator, a touchsensitive switch, a capacitive switch, pressure sensitive switch, jogwheel or the like, to input data or command to display device 1200 orotherwise control the operation of display device 1200. It is noted thatsome embodiments may include display-less devices or devices without anyuser interface components. These devices may be functionalized to storedata as a data logger and/or provide a conduit to transfer data from onbody electronics and/or a display-less device to another device and/orlocation. Embodiments will be described herein as display devices forexemplary purposes which are in no way intended to limit the embodimentsof the present disclosure. It will be apparent that display-less devicesmay also be used in certain embodiments.

In certain embodiments, on body electronics 1100 may be configured tostore some or all of the monitored analyte related data received fromanalyte sensor 14 in a memory during the monitoring time period, andmaintain it in memory until the usage period ends. In such embodiments,stored data is retrieved from on body electronics 1100 at the conclusionof the monitoring time period, for example, after removing analytesensor 14 from the user by detaching on body electronics 1100 from theskin surface where it was positioned during the monitoring time period.In such data logging configurations, real time monitored analyte levelis not communicated to display device 1200 during the monitoring periodor otherwise transmitted from on body electronics 1100, but rather,retrieved from on body electronics 1100 after the monitoring timeperiod.

In certain embodiments, input component 1210 of display device 1200 mayinclude a microphone and display device 1200 may include softwareconfigured to analyze audio input received from the microphone, suchthat functions and operation of the display device 1200 may becontrolled by voice commands. In certain embodiments, an outputcomponent of display device 1200 includes a speaker for outputtinginformation as audible signals. Similar voice responsive components suchas a speaker, microphone and software routines to generate, process andstore voice driven signals may be provided to on body electronics 1100.

In certain embodiments, display 1220 and input component 1210 may beintegrated into a single component, for example a display that candetect the presence and location of a physical contact touch upon thedisplay such as a touch screen user interface. In such embodiments, theuser may control the operation of display device 1200 by utilizing a setof pre-programmed motion commands, including, but not limited to, singleor double tapping the display, dragging a finger or instrument acrossthe display, motioning multiple fingers or instruments toward oneanother, motioning multiple fingers or instruments away from oneanother, etc. In certain embodiments, a display includes a touch screenhaving areas of pixels with single or dual function capacitive elementsthat serve as LCD elements and touch sensors.

Display device 1200 also includes data communication port 1230 for wireddata communication with external devices such as remote terminal(personal computer) 1700, for example. Example embodiments of the datacommunication port 1230 include USB port, mini USB port, RS-232 port,Ethernet port, Firewire port, or other similar data communication portsconfigured to connect to the compatible data cables. Display device 1200may also include an integrated in vitro glucose meter, including invitro test strip port 1240 to receive an in vitro glucose test strip forperforming in vitro blood glucose measurements.

Referring still to FIG. 1 , display 1220 in certain embodiments isconfigured to display a variety of information—some or all of which maybe displayed at the same or different time on display 1220. In certainembodiments the displayed information is user-selectable so that a usercan customize the information shown on a given display screen. Display1220 may include but is not limited to graphical display 1380, forexample, providing a graphical output of glucose values over a monitoredtime period (which may show important markers such as meals, exercise,sleep, heart rate, blood pressure, etc, numerical display 1320, forexample, providing monitored glucose values (acquired or received inresponse to the request for the information), and trend or directionalarrow display 1310 that indicates a rate of analyte change and/or a rateof the rate of analyte change, e.g., by moving locations on display1220.

As further shown in FIG. 1 , display 1220 may also include date display1350 providing for example, date information for the user, time of dayinformation display 1390 providing time of day information to the user,battery level indicator display 1330 which graphically shows thecondition of the battery (rechargeable or disposable) of the displaydevice 1200, sensor calibration status icon display 1340 for example, inmonitoring systems that require periodic, routine or a predeterminednumber of user calibration events, notifying the user that the analytesensor calibration is necessary, audio/vibratory settings icon display1360 for displaying the status of the audio/vibratory output or alarmstate, and wireless connectivity status icon display 1370 that providesindication of wireless communication connection with other devices suchas on body electronics, data processing module 1600, and/or remoteterminal 1700. As additionally shown in FIG. 1 , display 1220 mayfurther include simulated touch screen button 1250, 1260 for accessingmenus, changing display graph output configurations or otherwise forcontrolling the operation of display device 1200.

Referring back to FIG. 1 , in certain embodiments, display 1220 ofdisplay device 1200 may be additionally, or instead of visual display,configured to output alarms notifications such as alarm and/or alertnotifications, glucose values etc, which may be audible, tactile, or anycombination thereof. In one aspect, the display device 1200 may includeother output components such as a speaker, vibratory output componentand the like to provide audible and/or vibratory output indication tothe user in addition to the visual output indication provided on display1220. Further details and other display embodiments can be found in,e.g., U.S. patent application Ser. No. 12/871,901, U.S. ProvisionalApplication Nos. 61/238,672, 61/247,541, 61/297,625, the disclosures ofeach of which are incorporated herein by reference for all purposes.

After the positioning of on body electronics 1100 on the skin surfaceand analyte sensor 14 in vivo to establish fluid contact with ISF (orother appropriate body fluid), on body electronics 1100 in certainembodiments is configured to wirelessly communicate analyte related data(such as, for example, data corresponding to monitored analyte leveland/or monitored temperature data, and/or stored historical analyterelated data) when on body electronics 1100 receives a command orrequest signal from display device 1200. In certain embodiments, on bodyelectronics 1100 may be configured to at least periodically broadcastreal time data associated with monitored analyte level which is receivedby display device 1200 when display device 1200 is within communicationrange of the data broadcast from on body electronics 1100, i.e., it doesnot need a command or request from a display device to send information.

For example, display device 1200 may be configured to transmit one ormore commands to on body electronics 1100 to initiate data transfer, andin response, on body electronics 1100 may be configured to wirelesslytransmit stored analyte related data collected during the monitoringtime period to display device 1200. Display device 1200 may in turn beconnected to a remote terminal 1700 such as a personal computer andfunctions as a data conduit to transfer the stored analyte levelinformation from the on body electronics 1100 to remote terminal 1700.In certain embodiments, the received data from the on body electronics1100 may be stored (permanently or temporarily) in one or more memory ofthe display device 1200. In certain other embodiments, display device1200 is configured as a data conduit to pass the data received from onbody electronics 1100 to remote terminal 1700 that is connected todisplay device 1200.

Referring still to FIG. 1 , also shown in analyte monitoring system 100are data processing module 1600 and remote terminal 1700. Remoteterminal 1700 may include a personal computer, a server terminal alaptop computer or other suitable data processing devices includingsoftware for data management and analysis and communication with thecomponents in the analyte monitoring system 100. For example, remoteterminal 1700 may be connected to a local area network (LAN), a widearea network (WAN), or other data network for uni-directional orbi-directional data communication between remote terminal 1700 anddisplay device 1200 and/or data processing module 1600.

Remote terminal 1700 in certain embodiments may include one or morecomputer terminals located at a physician's office or a hospital. Forexample, remote terminal 1700 may be located at a location other thanthe location of display device 1200. Remote terminal 1700 and displaydevice 1200 could be in different rooms or different buildings. Remoteterminal 1700 and display device 1200 could be at least about one mileapart, e.g., at least about 100 miles apart, e.g., at least about 1000miles apart. For example, remote terminal 1700 could be in the same cityas display device 1200, remote terminal 1700 could be in a differentcity than display device 1200, remote terminal 1700 could be in the samestate as display device 1200, remote terminal 1700 could be in adifferent state than display device 1200, remote terminal 1700 could bein the same country as display device 1200, or remote terminal 1700could be in a different country than display device 1200, for example.

In certain embodiments, a separate, optional datacommunication/processing device such as data processing module 1600 maybe provided in analyte monitoring system 100. Data processing module1600 may include components to communicate using one or more wirelesscommunication protocols such as, for example, but not limited to,infrared (IR) protocol, Bluetooth® protocol, Zigbee® protocol, and802.11 wireless LAN protocol. Additional description of communicationprotocols including those based on Bluetooth® protocol and/or Zigbee®protocol can be found in U.S. Patent Publication No. 2006/0193375incorporated herein by reference for all purposes. Data processingmodule 1600 may further include communication ports, drivers orconnectors to establish wired communication with one or more of displaydevice 1200, on body electronics 1100, or remote terminal 1700including, for example, but not limited to USB connector and/or USBport, Ethernet connector and/or port, FireWire connector and/or port, orRS-232 port and/or connector.

In certain embodiments, data processing module 1600 is programmed totransmit a polling or query signal to on body electronics 1100 at apredetermined time interval (e.g., once every minute, once every fiveminutes, or the like), and in response, receive the monitored analytelevel information from on body electronics 1100. Data processing module1600 stores in its memory the received analyte level information, and/orrelays or retransmits the received information to another device such asdisplay device 1200. More specifically in certain embodiments, dataprocessing module 1600 may be configured as a data relay device toretransmit or pass through the received analyte level data from on bodyelectronics 1100 to display device 1200 or a remote terminal (forexample, over a data network such as a cellular or WiFi data network) orboth.

In certain embodiments, on body electronics 1100 and data processingmodule 1600 may be positioned on the skin surface of the user within apredetermined distance of each other (for example, about 1-12 inches, orabout 1-10 inches, or about 1-7 inches, or about 1-5 inches) such thatperiodic communication between on body electronics 1100 and dataprocessing module 1600 is maintained. Alternatively, data processingmodule 1600 may be worn on a belt or clothing item of the user, suchthat the desired distance for communication between the on bodyelectronics 1100 and data processing module 1600 for data communicationis maintained. In a further aspect, the housing of data processingmodule 1600 may be configured to couple to or engage with on bodyelectronics 1100 such that the two devices are combined or integrated asa single assembly and positioned on the skin surface. In furtherembodiments, data processing module 1600 is detachably engaged orconnected to on body electronics 1100 providing additional modularitysuch that data processing module 1600 may be optionally removed orreattached as desired.

Referring again to FIG. 1 , in certain embodiments, data processingmodule 1600 is programmed to transmit a command or signal to on bodyelectronics 1100 at a predetermined time interval such as once everyminute, or once every 5 minutes or once every 30 minutes or any othersuitable or desired programmable time interval to request analyterelated data from on body electronics 1100. When data processing module1600 receives the requested analyte related data, it stores the receiveddata. In this manner, analyte monitoring system 100 may be configured toreceive the continuously monitored analyte related information at theprogrammed or programmable time interval, which is stored and/ordisplayed to the user. The stored data in data processing module 1600may be subsequently provided or transmitted to display device 1200,remote terminal 1700 or the like for subsequent data analysis such asidentifying frequency of periods of glycemic level excursions over themonitored time period, or the frequency of the alarm event occurrenceduring the monitored time period, for example, to improve therapyrelated decisions. Using this information, the doctor, healthcareprovider or the user may adjust or recommend modification to the diet,daily habits and routines such as exercise, and the like.

In another embodiment, data processing module 1600 transmits a commandor signal to on body electronics 1100 to receive the analyte relateddata in response to a user activation of a switch provided on dataprocessing module 1600 or a user initiated command received from displaydevice 1200. In further embodiments, data processing module 1600 isconfigured to transmit a command or signal to on body electronics 1100in response to receiving a user initiated command only after apredetermined time interval has elapsed. For example, in certainembodiments, if the user does not initiate communication within aprogrammed time period, such as, for example about 5 hours from lastcommunication (or 10 hours from the last communication, or 24 hours fromthe last communication), the data processing module 1600 may beprogrammed to automatically transmit a request command or signal to onbody electronics 1100. Alternatively, data processing module 1600 may beprogrammed to activate an alarm to notify the user that a predeterminedtime period of time has elapsed since the last communication between thedata processing module 1600 and on body electronics 1100. In thismanner, users or healthcare providers may program or configure dataprocessing module 1600 to provide certain compliance with analytemonitoring regimen, so that frequent determination of analyte levels ismaintained or performed by the user.

In certain embodiments, when a programmed or programmable alarmcondition is detected (for example, a detected glucose level monitoredby analyte sensor 14 that is outside a predetermined acceptable rangeindicating a physiological condition) which requires attention orintervention for medical treatment or analysis (for example, ahypoglycemic condition, a hyperglycemic condition, an impendinghyperglycemic condition or an impending hypoglycemic condition), the oneor more output indications may be generated by the control logic orprocessor of the on body electronics 1100 and output to the user on auser interface of on body electronics 1100 so that corrective action maybe timely taken. In addition to or alternatively, if display device 1200is within communication range, the output indications or alarm data maybe communicated to display device 1200 whose processor, upon detectionof the alarm data reception, controls the display 1220 to output one ormore notification.

In certain embodiments, control logic or microprocessors of on bodyelectronics 1100 include software programs to determine future oranticipated analyte levels based on information obtained from analytesensor 14, e.g., the current analyte level, the rate of change of theanalyte level, the acceleration of the analyte level change, and/oranalyte trend information determined based on stored monitored analytedata providing a historical trend or direction of analyte levelfluctuation as function time during monitored time period. Predictivealarm parameters may be programmed or programmable in display device1200, or the on body electronics 1100, or both, and output to the userin advance of anticipating the user's analyte level reaching the futurelevel. This provides the user an opportunity to take timely correctiveaction.

Information, such as variation or fluctuation of the monitored analytelevel as a function of time over the monitored time period providinganalyte trend information, for example, may be determined by one or morecontrol logic or microprocessors of display device 1200, data processingmodule 1600, and/or remote terminal 1700, and/or on body electronics1100. Such information may be displayed as, for example, a graph (suchas a line graph) to indicate to the user the current and/or historicaland/or and predicted future analyte levels as measured and predicted bythe analyte monitoring system 100. Such information may also bedisplayed as directional arrows (for example, see trend or directionalarrow display 1310) or other icon(s), e.g., the position of which on thescreen relative to a reference point indicated whether the analyte levelis increasing or decreasing as well as the acceleration or decelerationof the increase or decrease in analyte level. This information may beutilized by the user to determine any necessary corrective actions toensure the analyte level remains within an acceptable and/or clinicallysafe range. Other visual indicators, including colors, flashing, fading,etc., as well as audio indicators including a change in pitch, volume,or tone of an audio output and/or vibratory or other tactile indicatorsmay also be incorporated into the display of trend data as means ofnotifying the user of the current level and/or direction and/or rate ofchange of the monitored analyte level. For example, based on adetermined rate of glucose change, programmed clinically significantglucose threshold levels (e.g., hyperglycemic and/or hypoglycemiclevels), and current analyte level derived by an in vivo analyte sensor,the system 100 may include an algorithm stored on computer readablemedium to determine the time it will take to reach a clinicallysignificant level and will output notification in advance of reachingthe clinically significant level, e.g., 30 minutes before a clinicallysignificant level is anticipated, and/or 20 minutes, and/or 10 minutes,and/or 5 minutes, and/or 3 minutes, and/or 1 minute, and so on, withoutputs increasing in intensity or the like.

Referring again back to FIG. 1 , in certain embodiments, softwarealgorithm(s) for execution by data processing module 1600 may be storedin an external memory device such as an SD card, microSD card, compactflash card, XD card, Memory Stick card, Memory Stick Duo card, or USBmemory stick/device including executable programs stored in such devicesfor execution upon connection to the respective one or more of the onbody electronics 1100, remote terminal 1700 or display device 1200. In afurther aspect, software algorithms for execution by data processingmodule 1600 may be provided to a communication device such as a mobiletelephone including, for example, WiFi or Internet enabled smart phonesor personal digital assistants (PDAs) as a downloadable application forexecution by the downloading communication device.

Examples of smart phones include Windows®, Android™, iPhone® operatingsystem, Palm® WebOS™, Blackberry® operating system, or Symbian®operating system based mobile telephones with data network connectivityfunctionality for data communication over an internet connection and/ora local area network (LAN). PDAs as described above include, forexample, portable electronic devices including one or moremicroprocessors and data communication capability with a user interface(e.g., display/output unit and/or input unit, and configured forperforming data processing, data upload/download over the internet, forexample. In such embodiments, remote terminal 1700 may be configured toprovide the executable application software to the one or more of thecommunication devices described above when communication between theremote terminal 1700 and the devices are established.

In still further embodiments, executable software applications may beprovided over-the-air (OTA) as an OTA download such that wiredconnection to remote terminal 1700 is not necessary. For example,executable applications may be automatically downloaded as softwaredownload to the communication device, and depending upon theconfiguration of the communication device, installed on the device foruse automatically, or based on user confirmation or acknowledgement onthe communication device to execute the installation of the application.The OTA download and installation of software may include softwareapplications and/or routines that are updates or upgrades to theexisting functions or features of data processing module 1600 and/ordisplay device 1200.

Referring back to remote terminal 1700 of FIG. 1 , in certainembodiments, new software and/or software updates such as softwarepatches or fixes, firmware updates or software driver upgrades, amongothers, for display device 1200 and/or on body electronics 1100 and/ordata processing module 1600 may be provided by remote terminal 1700 whencommunication between the remote terminal 1700 and display device 1200and/or data processing module 1600 is established. For example, softwareupgrades, executable programming changes or modification for on bodyelectronics 1100 may be received from remote terminal 1700 by one ormore of display device 1200 or data processing module 1600, andthereafter, provided to on body electronics 1100 to update its softwareor programmable functions. For example, in certain embodiments, softwarereceived and installed in on body electronics 1100 may include softwarebug fixes, modification to the previously stalled software parameters(modification to analyte related data storage time interval, resettingor adjusting time base or information of on body electronics 1100,modification to the transmitted data type, data transmission sequence,or data storage time period, among others). Additional detailsdescribing field upgradability of software of portable electronicdevices, and data processing are provided in U.S. application Ser. Nos.12/698,124, 12/794,721, now U.S. Pat. No. 8,595,607, Ser. Nos.12/699,653, and 12/699,844, and U.S. Provisional Application Nos.61/359,265, and 61/325,155 the disclosures of which are incorporated byreference herein for all purposes.

The Sensor

The analyte sensor 14 of the analyte measurement system 100 may be usedto monitor levels of a wide variety of analytes. Analytes that may bemonitored include, for example, acetylcholine, amylase, bilirubin,cholesterol, chorionic gonadotropin, creatine kinase (e.g., CK-MB),creatine, DNA, fructosamine, glucose, glutamine, growth hormones,hormones, ketones, lactate, peroxide, prostate-specific antigen,prothrombin, RNA, thyroid-stimulating hormone, and troponin. Theconcentration of drugs, such as, for example, antibiotics (e.g.,gentamicin, vancomycin, and the like), digitoxin, digoxin, drugs ofabuse, theophylline, and warfarin, may also be monitored. One or moreanalytes may be monitored by a given sensor. In those embodiments thatmonitor more than one analyte, the analytes may be monitored at the sameor different times, which may use the same on body electronics (e.g.,simultaneously) or with different on body electronics.

In one embodiment of the present disclosure, sensor 14 is physicallypositioned in or on the body of a user whose analyte level is beingmonitored. Sensor 14 may be configured to continuously sample theanalyte level of the user and convert the sampled analyte level, e.g.,glucose concentration into a corresponding data signal, e.g., a currentor voltage, for input into on body electronics. Alternatively, sensor 14may be configured to sample analyte levels on demand. The on bodyelectronics may amplify, filter, average, and/or otherwise processsignal provided by the sensor.

An embodiment of the sensor 14 is illustrated in FIG. 2 . It isunderstood that the inserters described herein can be used with othermedical devices. The shape(s) described herein are exemplary only. Othersensor shapes are contemplated. In some embodiments, sensor 14 includesa substrate which is a dielectric, e.g., a polymer or plastic material,such as polyester or polyamide. In this embodiment, the sensor isconstructed so that a portion is positionable beneath skin and a portionis above skin. Accordingly, sensor 14 includes an insertion or internalportion 30 and an external or electrical contact portion 32. In someembodiments, the contact portion 32 includes several conductive contacts36, 38, and 40 (herein shown as three contacts) for connection to otherelectronics, e.g., at the on body electronics 1100 (See FIG. 1 ). Thecontacts provided in this embodiment are for a working electrode, areference electrode, and a counter electrode. In some embodiments, twoor more working electrodes are provided. The operative portions of theseelectrodes, that is, working electrode, reference electrode, and counterelectrode (not individually shown), are provided at the insertionportion, e.g., at the distal end of insertion portion 30, e.g., portion34. In some embodiments, one or more electrodes may be external to thebody, e.g., an external counter electrode. The contact and operativeportions of the electrodes are connected by circuit traces 42, 44, and46 running on the surface of the substrate. In some embodiments, thetraces are provided in channels, or may be embedded within thesubstrate, or may traverse different sides of the substrate. Theconductive contacts, conductive traces, and electrodes are fabricatedfrom conductive material, such as platinum, palladium, gold, carbon, orthe like. More than one material may be used for a given sensor. Furtherdetails of sensors are described, e.g., in U.S. Pat. Nos. 6,175,572 and6,103,033, which are incorporated by reference herein for all purposes.

Sensor 14 may include a proximal retention portion 48. The insertionportion 30 and the proximal retention portion 48 are sized andconfigured to be positioned with a sharp for installation into the skinof a subject, as described herein. In use, the sensor 14 may beconfigured to bend (e.g., along the line B) and therefore be positionedin two substantially perpendicular, intersecting planes. Such bendingmay occur prior to or during coupling to the on body electronics asdescribed below (See FIG. 17 ).

Portions 48 and 52 provide a path for electrical connections, e.g., theconductive traces, between the proximal and distal portions of thesensor. Sensor 14 is further provided with a notch or cut-out 54. Suchconfiguration facilitates the sensor 14 to bend (e.g., along the lineindicated by line B) such that retention portion 48 remains upright andtherefore be positioned in two substantially perpendicular, intersectingplanes, as illustrated in FIG. 3 . As will be described below, thesensor tab 50 can be encased in the on body housing 122 to aid insecuring and positioning the sensor 14. Proximal retention portion 48maintains its longitudinal alignment with insertion portion 30 forpositioning within an insertion sharp.

Embodiments of analyte sensors have been described herein to operateelectrochemically, through an arrangement of electrodes having chemicalsensing layers applied thereto, by generating an electrical currentproportional to the volume of a redox reaction of the analyte (andindicative of analyte concentration), catalyzed by an analyte-specificoxidizing enzyme. Embodiments exist in which the number of electrodesprovided to bring about and detect the level of these reactions is two,three, or a greater number. However, other types of sensors may beemployed as described herein.

A portion of sensor 14 may be situated above the surface of the skin,with a distal portion 30 penetrating through the skin and into thesubcutaneous space in contact with the user's biofluid, such as ISF.Further details regarding the electrochemistry of sensor 14 is providedin U.S. Pat. Nos. 5,264,104; 5,356,786; 5,262,035; 5,320,725; and6,990,366, each of which is incorporated by reference herein for allpurposes.

In some embodiments, the sensor is implantable into a subject's body fora usage period (e.g., a minute or more, at least one day or more, aboutone to about 30 days or even longer, about three to about fourteen days,about three to about seven days, or in some embodiments, longer periodsof up to several weeks) to contact and monitor an analyte present in abiological fluid. In this regard, the sensor can be disposed in asubject at a variety of sites (e.g., abdomen, upper arm, thigh, etc.),including intramuscularly, transcutaneously, intravascularly, or in abody cavity.

In some embodiments, sensor 14 is employed by insertion and/orimplantation into a user's body for some usage period. In suchembodiments, the substrate may be formed from a relatively flexiblematerial.

While the embodiments illustrated in FIGS. 2-3 have three electrodes,other embodiments can include a fewer or greater number of electrodes.For example, a two-electrode sensor can be utilized. The sensor 14 maybe externally-powered and allow a current to pass which is proportionalto the amount of analyte present. Alternatively, the sensor 14 itselfmay act as a current source in some embodiments. In some two-electrodeembodiments, the sensor may be self-biasing and there may be no need fora reference electrode. An exemplary self-powered, two-electrode sensoris described in U.S. patent application Ser. No. 12/393,921, filed Feb.26, 2009, and entitled “Self-Powered Analyte Sensor,” which is herebyincorporated by reference herein for all purposes. The level of currentprovided by a self-powered sensor may be low, for example, on the orderof nanoamperes, in certain embodiments.

Insertion Assembly

Insertion assemblies are provided which are used to install a medicaldevice to the subject. In some embodiments, an insertion assemblyincludes an inserter and the medical device itself. The inserter can beconfigured to insert various medical devices into the subject, such as,for example, an analyte sensor, an infusion set, or a cannula. In someembodiments, the inserter can be configured to install a combination ofsuch devices, e.g., a combined sensor/infusion set, etc., at the same ordifferent times or locations. For example, in certain embodiments, agiven inserter can be configured to install a first device and a seconddevice at different times. In this regard, the inserter can be reusable.For example, an inserter may be modifiable to be used with more than onemedical device, to include more than one type of medical device, e.g.,by attaching an adapter and/or detaching a portion of an inserter. Theinserter can install the medical device in, under, or through the skinof the subject, or place the medical device on the surface of the skin.The medical device can include features or structures, e.g., barbs,tabs, adhesive, etc., to maintain the device in position with respect tothe skin after insertion. The inserter device may also be used as alancet, e.g., to pierce the skin without inserting or installing amedical device.

In some embodiments, an insertion assembly includes an inserter, amedical device, such as an analyte sensor, and a mount for supportingthe medical device at least partially in or on the skin of the subject.In some embodiments, the mount is a support structure, plate and/ormember which is attached, adhered, or otherwise secured to the skin ofthe subject. The mount may be inserted simultaneously with the medicaldevice by the inserter. In other embodiments, the mount is installedafter or before installation of the medical device. A mount may beapplied by the inserter or separately. The mount may include features orstructures (e.g., adhesive, guides, barbs, tabs, etc.) to maintain thesensor in position with respect to the skin after insertion and/ormaintain the sensor in relative position with respect to the sensorcontrol unit. In some embodiments, an adhesive pad or strip is used tosecure the medical device, e.g., the sensor and/or the sensor controlunit, and no mount is used.

In some embodiments, an insertion assembly includes an inserter, ananalyte sensor, a mount, and a power supply. The mount and power supplymay be inserted simultaneously with the analyte sensor by the inserter.In other embodiments, the mount and battery are installed after orbefore installation of the analyte sensor. In such case, the mountand/or power supply may be applied by the inserter or separately. Thepower supply may be used to provide a current or a potential to thesensor and/or to provide power for communication of one or more signalsto the monitor unit.

In some embodiments, an insertion assembly includes an inserter, amedical device such as an analyte sensor, a mount, and a sensor controlunit. The mount and sensor control unit may be deployed and/or installedsimultaneously with the analyte sensor by the inserter. In otherembodiments, the mount and sensor control unit are installed after orbefore installation of the analyte sensor. For example, the mount andthe analyte sensor may be installed by the inserter, and the sensorcontrol unit may be subsequently installed. In other embodiments, themount is installed, followed by insertion of the analyte sensor by theinserter, and further followed by installation of the sensor controlunit. In other embodiments, the mount and sensor control unit areinstalled first, and the analyte sensor is subsequently installed.

In some embodiments, electronics of the sensor control unit provide avoltage or current to the analyte sensor. In some embodiments, theelectronics processes signals are provided by the analyte sensor. Infurther embodiments, the electronics may include communicationfunctionality for providing signal relating to signal provided by theanalyte sensor to a further component, such as, e.g., a monitor unit, acomputer, or other component. In some embodiments, communicationscircuitry, such as RFID antenna or other communications circuitry, isprovided. The power supply may be used to power some or all of thesefunctions. In some embodiments, power is provided from the monitor unit,e.g., via inductive coupling.

An inserter may include a plurality of different components. Forexample, an inserter may include one or more components for advancing asharp towards the skin of the subject. The sensor and sensor controlunit and/or mounting structure may be supported by a support structure,such as a carriage. A driver may be provided for advancing the sharpand/or the analyte sensor/support structure. In some embodiments, theactuator is directly or indirectly coupled to the sharp and/or supportstructure, such that manual force and speed applied by the subject tothe actuator is transferred to the sharp and/or support structure. Insome embodiments, the applied force drives the sharp and/or supportstructure between a retracted position and an advanced position. In someembodiments, the sensor and sensor control unit and/or mountingstructure is maintained in a retracted position prior to installation bycontacting projections extending inwardly from a sheath. In accordancewith this embodiment, the sensor and sensor control unit and/or mountingstructure are temporarily maintained operatively between the supportstructure and the projections disposed on the interior wall of thesheath.

An inserter can also include one or more components for retracting thesharp, while allowing the analyte sensor and optional mount and/orelectronics to remain on the subject. The components for retracting thesharp can include a retractor. It is understood that the retractor andthe actuator may be the same structure or include some commoncomponents. In some embodiments, the retractor is directly or indirectlycoupled to the sharp such that the manual force applied by the user istransferred from the retractor to the sharp to retract the sharp fromthe skin. In other embodiments, a drive assembly may be provided toretract the sharp. For example, the drive assembly may include a spring,motor, hydraulic piston, etc., to retract the sharp away from the skinof the subject. The drive assembly may also include a linear drivecomponent.

In some embodiments, the retractor withdraws the sharp upon actuation bythe user. In such cases, the user actuates the retractor when it isdesired to withdraw the sharp. For example, the retractor may include arelease switch. Upon activation of the release switch, the driveassembly, e.g., the spring or other driver, retracts the sharp from theskin. In other embodiments, the retractor and the actuator includecommon components. After activating the actuator to advance the sharpand the analyte sensor, the user releases the actuator, which allows thedrive assembly to withdraw the sharp from the skin.

In some embodiments, the retractor withdraws the sharp without furtheruser interaction after actuation of insertion. For example, the insertermay include features or components which automatically retract the sharpupon advancement of the sharp and support structure by a predeterminedamount. Inserter devices, in which no further action by the user isrequired to initiate withdrawal of the sharp after insertion, arereferred to herein as having “automatic” withdrawal of the sharp.

Inserter Devices

One embodiment of a needle hub for an inserter is illustrated in FIGS.4-5 . Needle hub 136 supports sharp 124, having a sharpened distalportion 160. In some embodiments, as discussed herein, a longitudinalwall opening or gap 162 is provided in at least a portion of the wall ofthe sharp 124. The length N of the gap 162 is selected to becommensurate with the length of the insertion portion 30 through to theproximal retention portion 48 of the sensor, and in certain embodimentsmay be about 3 mm to about 50 mm, e.g., about 5 mm, or about 10 mm, orabout 15 mm, or about 20 mm. The length L of the sharp 124 may be about3 mm to about 50 mm, e.g., 5 mm or more, or about 10 mm, or about 20 mm,or about 30 mm, or about 50 mm, and is selected based upon the length ofthe insertion portion 30 of a sensor and the desired depth of theinsertion portion 30 of the sensor 14. In some embodiments, the distanceor spacing between the two edges of the gap is about 0.2 mm to about 0.5mm e.g., about 0.22 mm, about 0.25 mm, etc.

The distal portion 160 of sharp 124 is illustrated in greater detail inFIGS. 6-8 . As illustrated in FIG. 6 , sharp 124 has a substantially“C”- or “U”-shaped profile in this embodiment, but may have otherconfigurations, e.g., substantially “V”-shaped. A longitudinal gap 162is provided in the wall of the sharp 124. FIG. 7 illustrates distalportion 160 as provided with an angled tip. In some embodiments, theangled tip may be provided with a first angled tip portion 164 and asecond steep-angled tip portion 166. The exemplary configuration, whichincludes multiple edges and faces, provides a sharp point to reducepenetration force, trauma, and bleeding for the subject. The distalsection of the sensor body has a width sized to fit within the gap 162of the insertion sharp 124 having a diameter less than about 20 gauge toabout 26 gauge, e.g., 21 gauge to about 25 gauge, where in certainembodiments the sharp is 21 gauge or 23 gauge or 25 gauge. Such sharpmay be used with a sensor having a width or diameter—at least theportion that is carried by the sharp—of about 0.20 mm to about 0.80 mm,e.g., about 0.25 mm to about 0.60 mm, where, in some embodiments, thewidth or diameter of at least a portion of a sensor is 0.27 mm or 0.33mm or 0.58 mm. In some embodiments, sharp 124 is fabricated from a sheetof metal and folded into a substantially “V,” “U” or “C” configurationin cross-section. Various technologies can be used to manufacture afolded sheet of metal to form sharp 124. For example, etched-sheet metaltechnology can be used to form the sharp 124. In this manner, the sharpcan be formed having a very sharp edge so that penetration through theskin during insertion is less painful. In other embodiments, aprogressive die technology may be utilized to form a complex sheet-metalshape that has a sharp edge as depicted in FIG. 9 . In some embodiments,the sharp 124 can be molded with a plastic cap so that the sharp can behandled during the inserter assembly process. Further, the die cut sharpmay be molded with plastic to reinforce the “V,” “U” or “C” shaped sheetmetal configuration. In other embodiments, a laser-cut sharp can beformed. In this manner, the laser can be used to form the wall openingor gap 162 and first-angled tip portion 164 and a second, steep-angledtip portion 166.

In another embodiment, a sharp 124 may be formed from a standardhypodermic needle utilizing the method depicted in FIG. 10 . First, thehypodermic needle (having a circular cross-section) is cut to thedesired length for sharp 124. Next, the hypodermic needle is compressedso that its cross-section is permanently deformed from a circular shapeto an oval shape. The tip of the hypodermic needle is then ground to abevel to produce a sharp point to reduce the required penetration force,as previously discussed. Finally, the top section of the needle isremoved by appropriate techniques (e.g., grinding, electropolishing,etc.). The resulting sharp 124 has a “U”-shaped configuration andprovides ample space for the insertion of sensor 14. In someembodiments, the tip-grinding step and the compression step may becarried out in reversed order.

Due to the compression step, a user may initially start with a largerdiameter hypodermic needle so that the finished sharp 124 will havesimilar dimensions to the previously described sharps.

FIGS. 11-12 illustrate the position of on body housing 122 with respectto the needle hub 136 and sharp 124. The on body housing 122 can beconfigured to hold at least a portion of sensor 14 and sensor controlunit. As illustrated in FIG. 11 , the sharp 124 extends through anaperture 168 in the on body housing 122. Thus, in some embodiments, thesharp 124 is uncoupled to on body housing 122. The distal portion ofsensor 14 is positioned within the sharp 124. As further illustrated inFIG. 12 , electronics of the sensor control unit (e.g., a printedcircuit board containing electronics components of the on-body unit) andsensor hub 123 are positioned within on body housing 122. Sensor 14 mayinclude a positioning structure, or slit 127, which receives apositioning member, such as tab 129 of sensor hub 123. A power supply82, such as a battery, e.g., a single use disposable battery, orrechargeable battery, is provided. The power supply 82 is used toprovide potential or current to the sensor in some embodiments. Inembodiments where a passive communications protocol such as passive RFIDis used, no power supply is provided for the communications. Such poweris provided by the monitor unit. In some embodiments, where the sensorcontrol unit is used to transmit one or more signals, one or more powersupplies may be used to provide power for such communications circuitry.In some embodiments, the active operational life of the battery mayexceed the active operational life of the sensor 14.

FIG. 13 illustrates in cross-section the orientation of the on bodyhousing 122 with respect to the sharp 124 of an inserter, such asinserter 1500 (see FIG. 52 ). As discussed herein, sensor 14 is disposedin a substantially bent configuration in some embodiments, such that aportion of the sensor, e.g., the insertion portion 30 and the proximalretention portion 48, are substantially vertical (e.g., substantiallyaligned with the longitudinal axis of an inserter and substantiallyperpendicular to the skin surface) and the contact portion 32 (shown inprofile) is oriented in a substantially horizontal configuration, and inelectrical contact with the data-processing unit electronics, such ascircuit 80. The sensor tab 50 can be encased in the plastic of the onbody housing 122 (e.g., “overmolded”) and secured in place. The notch 56provides further stability to the sensor 14, e.g., by allowing thesensor tab 50 to be encased by the material of the on body housing 122,and further provides a means for vertically orienting the sensor 14during mounting, e.g., by allowing vertical positioning of the notch 56with respect to a vertical landmark of the on body housing 122.

The sensor 14, mounted with the on body housing 122, can be disposedwithin a recess of the carriage 130 such as a concave recess in thecarriage 130. Alternatively, the sensor 14, mounted with the on bodyhousing 122, can be disposed between the support structure and one ormore projections extending from the wall of the sheath. In yet anotheralternative, the sensor 14, mounted with the on body housing 122, can beheld in position by a releasable friction fit coupling to the sharp 124.In this manner, the carriage need not have a recess within which thesensor mounted with the on body housing is disposed. In the initialconfiguration of the inserter, the sharp 124 extends through alongitudinal aperture 168 formed in a carriage 130. In some embodiments,the aperture 168 is appropriately sized, such that neither the sharp 124nor needle hub 136 is in contact with the carriage 130. Accordingly, theneedle hub 136 (and sharp 124) on the one hand, and the carriage 130(FIG. 13 ) and the on body housing 122, on the other hand, movesimultaneously, but independently from one another. In otherembodiments, a friction fit may be provided between the aperture and thesharp.

The insertion portion 30 and proximal retention portion 48 of the sensor14 are disposed within a longitudinal bore 162 within the sharp 124(See, e.g., FIG. 6 ). The proximal retention portion 48 is disposedwithin the longitudinal bore of the sharp 124 and provides additionalstability to the mounting of the sensor 14 within the sharp 124. Thelongitudinal wall gap or opening 162 of sharp 124 is aligned with thesensor 14, such that the tab 50 and the contact portion 32 extendlaterally outward from the sharp 124.

An embodiment of an inserter is illustrated in FIGS. 14-17 . An inserter900 includes a handle 902 and may include a removable distal cap or seal(not shown) for maintaining a sterile environment for the medical deviceand sharp housed therein. As illustrated in FIG. 14 , distal cap or sealis removed from handle 902. Inserter 900 includes a base 942 thatdefines a distal surface 912 for placement on the skin of a subject.Inserter 900 may be utilized to advance a medical device into the skinof the subject. In some embodiments, handle 902 is advanced relative tobase 942 in order to advance the sensor into the skin of the patient.

As illustrated in FIG. 15 , the inserter 900 includes an initialconfiguration in which the handle 902 is disposed in a proximal positionwith respect to the base 942. In such configuration, the sharp 924 isdisposed in a configuration spaced apart from the aperture 920 of theadhesive layer 918. Extending distally from the upper surface of handle902 are side walls 974, which terminate in a shoulder portion 975.

Needle carrier 934 is axially slidable within handle 902 and base 942 inthe direction of arrow N. Needle carrier 934 supports needle hub 936,from which sharp 924 extends longitudinally within the inserter 900. Insome embodiments, the sharp is supported at an oblique angle, e.g.,between 0° and 90° with respect to the skin surface. Initially, needlecarrier 934 is coupled to inner rail 928 through inter-engagement offinger 986 of needle carrier 934 with shoulder 987 of inner rail 928.

Inserter 900 includes an advancement spring 947. Inner rail 928 includesa spring retention portion 984 for advancement spring 947. The innersurface of handle 902 serves as an upper engagement surface foradvancement spring 947. In some embodiments, spring retention portion984 is fabricated having several projections that extend through anaperture 982 in the wall of base 942. Spring retention portion 984 isresiliently movable. As downward force is applied to handle 902, theledge 937 of handle 902 contacts spring retention portion 984, drivingsuch projections inward. Such inward motion releases the inner rail 928,and allows advancement spring 947 to advance the inner rail 928distally, thereby advancing the sharp 924 into the skin of the subject,as illustrated in FIG. 16 .

Retraction spring 946 is disposed between spring retention portion 948of base 942 and shoulder portion 949 of needle carrier 934. Initially,retraction spring 946 is in a compressed state. As carriage 930 reachesa distal position, the distal surface of the on body housing 122 engagesthe upper surface of adhesive pad 918, thereby becoming adhered to theskin surface S of the subject. At the same time, flanges 970 of base 942engage fingers 986 disposed on the needle carrier 934. Fingers 986 arepivoted outwards by flanges 970. Such pivoting of fingers causes fingers986 to become disengaged from shoulder 984 of inner rail 928. Shuttle934 is thereby disengaged from inner rail 928.

As illustrated in FIG. 17 , disengagement of the shuttle 934 from theinner rail 928 permits the spring 946 to expand, thereby advancing theneedle carrier 934 to a proximal position, thereby withdrawing the sharp924 from the skin of the subject, while leaving the sensor 14 in theskin.

A further embodiment of an inserter is illustrated in FIGS. 18-21 anddesignated inserter 1000. Inserter 1000 is substantially identical toinserter 900 described herein, with the substantial differences notedherein and illustrated in the accompanying figures.

An inserter 1000 includes a housing 1002, and may include a removabledistal cap or seal (not shown) for maintaining a sterile environment forthe medical device and sharp housed therein. As illustrated in FIG. 18 ,distal cap or seal is removed from housing 1002. Inserter 1000 includesa base 1042 which defines a distal surface 1012 for placement on theskin of a subject. Inserter 1000 may be utilized to advance a medicaldevice into the skin of the subject. In some embodiments, side buttons1084 are depressed relative to base 1042 in order to advance the medicaldevice into the skin of the patient.

As illustrated in FIG. 19 , the inserter 1000 includes an initialconfiguration in which the sharp 1024 is disposed in a configurationspaced apart from distal portion 1012 of the base 1042. It is understoodthat inserter 1000 may incorporate an adhesive layer (not shown)positioned across the distal portion 1012 of base 1042.

On-body unit inserter 1028 includes carriage 1030 for supporting on bodyhousing 122. On-body unit inserter 1028 also includes flange 1029 whichnormally rests on shoulder portions 1086 (as illustrated in FIGS. 19-21). When side buttons 1084 are depressed inwardly, latch portions onflange 1029 are deflected from engagement with shoulder portions 1086.As illustrated in FIG. 20 , advancement spring 1047 is released fromcompression, thereby advancing on-body unit inserter 1028 as elsewhere,along with needle carrier 1034 into the skin of the subject.

Retraction spring 1046 is disposed between needle carrier 1034 andhousing 1002. Initially, retraction spring 1046 is in a compressedstate. As carriage 1030 reaches a distal position, on-body unit inserter1028 is disengaged from needle carrier 1034. The distal surface of theon body housing 122 engages the skin or the upper surface of adhesivepad (not shown), thereby becoming adhered to the skin surface S of thesubject. Latches on needle carrier 1034 attach it to on-body unitinserter 1028. Upon firing the inserter by pressing tabs 1084, theon-body unit inserter 1028 is pushed by spring 1047 towards the skinsurface, bringing along needle carrier 1034 and loading extension spring1046. As on-body unit inserter 1028 reaches the distal position (towardsthe skin of the subject), protrusions on housing 1002 disengage latcheson needle carrier 1034, connecting it to on-body unit inserter 1028.Extension spring 1046 now pulls needle carrier 1034 back into theproximal position.

As illustrated in FIG. 21 , disengagement of the needle carrier 1034from on-body unit inserter 1028 permits the spring 1046 to contract withthe bias, thereby advancing the needle carrier 1034 to a proximalposition and withdrawing the sharp 1024 from the skin of the subject,while leaving the sensor 14 in the skin.

A further embodiment of an inserter is illustrated in FIGS. 22-25 .Inserter 1100B is substantially identical to inserters 900 and 1000described herein, with the substantial differences noted herein andillustrated in the accompanying figures.

An inserter 1100B includes a housing 1102 and may include a removabledistal cap or seal (not shown) for maintaining a sterile environment forthe medical device and/or sharp housed therein. As illustrated in FIG.22 , distal cap or seal is removed from housing 1102. Inserter 1100Bincludes a base 1142 which defines a distal surface 1112 for placementon the skin of a subject. Inserter 1100B may be utilized to advance amedical device into the skin of the subject. In some embodiments, amanual actuator bar 1114 is depressed relative to base 1142 in order toadvance the medical device into the skin of the patient. It isunderstood that inserter 1100B may incorporate an adhesive layer (notshown) which is positioned across the distal portion 1112 of base 1142.

As illustrated in FIG. 23 , the inserter 1100B includes an initialconfiguration in which the sharp 1124 is disposed in a configurationspaced apart from distal portion 1112 of the base 1142. Manualadvancement of the actuator may be performed by distal advancement ofactuator bar 1114.

On-body unit inserter 1128A includes carriage 1130 for supporting onbody housing 122. Retraction spring 1146 is disposed between needlecarrier 1134 and base 1142. Initially, retraction spring 1146 is in acompressed state. As actuator bar 1114 is moved distally, carriage 1130is moved distally and reaches a distal position, such that flanges 1188of base 1142 engage fingers 1186 disposed on the shuttle 1134. Fingers1186 are pivoted outwards by flanges 1188. Such pivoting of fingers 1186causes fingers 1186 to become disengaged from shoulder 1187 of innerrail 1128. Shuttle 1134 is thereby disengaged from inner rail 1128. Thedistal surface of the on body housing 122 engages the skin or the uppersurface of adhesive pad (not shown), thereby becoming adhered to theskin surface of the subject (FIG. 24 ).

As illustrated in FIG. 25 , disengagement of the shuttle 1134 from theinner rail 1128 permits the spring 1146 to expand with the bias, therebyadvancing the needle carrier 1136 to a proximal position and withdrawingthe sharp 1124 from the skin of the subject, while leaving the sensor 14in the skin. Once the sharp 1124 has been withdrawn from the subject, itis no longer accessible from the distal portion of the inserter 1100B,and unable to make contact by accident with the subject's skin.

A further embodiment of an inserter is illustrated in FIGS. 26-36 .Inserter 1200 is substantially identical to inserters 900, 1000, and1100B described herein, with the substantial differences noted hereinand illustrated in the accompanying figures.

Inserter 1200 includes a housing 1202, an on-body unit inserter 1228, aneedle retractor 1234, an inserter base 1212, and a rotor 1208 with atorsion spring (not shown), all of which are depicted separately inFIGS. 28-31 . As illustrated in FIGS. 28-31 , housing 1202 includesslots 1254; on-body unit inserter 1228 includes slots 1252, tabs 1253,and opening 1262; needle retractor 1234 includes tabs 1250 and opening1260; and rotor 1208 includes rotor follower 1264.

FIG. 32 illustrates an exploded view of inserter 1200. As illustrated,in some embodiments, inserter 1200 includes housing 1202, on-body unitinserter 1228, needle retractor 1234, and rotor 1208. Tabs 1250 can bedisposed on needle retractor 1234 and configured to engage slots 1252disposed on on-body unit inserter 1228 when assembled as shown in FIG.33 . Tabs 1253 can be disposed on on-body unit inserter 1228 andconfigured to engage slots 1254 disposed on housing 1202. Needleretractor 1234 and on-body unit inserter 1228 can each contain openings(1260, 1262) to receive rotor follower 1264 disposed on rotor 1208 afterrotor 1208 has been inserted into housing 1202. Additionally, on-bodyunit inserter 1228 can provide support for on body housing 122 (notshown) for installation to the skin of a subject.

As illustrated in FIG. 34 , in some embodiments, manually depressing theon-body unit inserter 1228 can cause the torsion spring to wind as therotor 1208 rotates, guided by the cam path. As illustrated in FIG. 35 ,continued distal advancement of the on-body unit inserter 1228 causesthe rotor follower 1264 to go “over center” within cam. At such point,the torsion spring (not shown) is allowed to unwind. With reference toFIG. 36 , further unwinding of the torsion spring pulls up the needleretractor 1234 from the insertion site, while leaving the on-body unitinserter in place.

A further embodiment of an inserter is illustrated in FIGS. 37-46 .Inserter 1300 is substantially identical to inserters 900, 1000, 1100B,and 1200 described herein, with the substantial differences noted hereinand illustrated in the accompanying figures.

Inserter 1300 includes a housing 1302, an on-body unit inserter 1334, aneedle retractor 1328, and a rotor 1308 with torsion spring 1365. Asillustrated in FIGS. 37, 38, 39, 45 and 46 , the on-body unit inserter1334 and needle retractor 1328 are disposed within the housing 1302.Rotor 1308 includes a rotor follower 1364 which engages a slot 1362provided in the needle retractor 1328 and a slot 1360 in the on-bodyunit inserter 1334. The on-body unit inserter 1334 provides a supportportion for supporting on body housing 1302 (not shown).

In operation, torsion spring 1365 is loaded. A release button (notshown) is depressed in order to release torsion spring 1365. Rotor 1308drives on-body unit inserter 1334 and needle retractor 1328 downwardlysimultaneously. A compression spring 1367 holds down on-body unitinserter 1334. As rotor 1308 continues to rotate, slot 1360 allowson-body unit inserter 1334 to travel down and then be held down, whileslot 1362 allows needle retractor 1328 to travel down and then back upto lift the needle from insertion site.

A further embodiment of an inserter is illustrated in FIGS. 47-51 .Inserter 1400 is substantially identical to inserters 900, 1000, 1100B,1200, and 1300 described herein, with the substantial differences notedherein and illustrated in the accompanying figures.

Inserter 1400 may be used for installation of a medical device, e.g., onbody housing 122, in connection with a cartridge or carrier 1406. Insome embodiments, inserter 1400 includes a body 1402 and an actuator1404. The carrier 1406 may include a needle hub 1436 including a sharp(not shown) as well as an on body housing 122. In use, the body 1402 isplaced on a mount 1408 attached to subject by use of an adhesive pad1418. As shown in FIG. 47 , carrier 1406 is loaded into inserter 1400laterally as shown.

With reference to FIG. 48 , a first disposable portion of inserter 1400includes adhesive pad 1418 and mount 1408. The second disposable portionof inserter 1400 includes carrier 1406 which removably contains needlehub 1436 and sensor hub 1437 (not shown) which is substantiallyidentical to on body housing 122 described herein. Inserter 1400 furtherincludes body 1402, actuator 1404, and return spring 1409 (not shown).Mount 1408 is removably attached to body 1402. Carrier 1406 can be slidon to body 1402 to transfer needle hub 1436 and carrier 1406 to inserter1400. As shown in FIG. 48 , carrier 1406 can then be removed frominserter 1400. Needle hub 1436 and sensor hub 1437 remain in inserter1400. Adhesive pad 1418 is then adhesively applied to the skin of asubject. Alternatively, adhesive pad 1418 may be applied to the skin ofa subject before attaching body 1402 and mount 1408.

In FIG. 49 , actuator 1404 is pressed down, performing a manualinsertion of needle hub 1436 and sensor hub 1437, with the needlelocated in needle hub 1436 and a distal sensor portion penetrating theskin of the subject. When pressure is released from actuator 1404,return spring 1409 (not shown) retracts the needle from the skin of thesubject and out of sensor hub 1437. As shown in FIG. 50 , body 1402 canbe removed from mount 1408, leaving sensor hub 1437 in mounting base1408. In FIG. 51 , in some exemplary embodiments, carrier 1406 is slidon to housing 1402, transferring needle 1436 to carrier 1406. Carrier1406, with needle 1436, is then removed from housing 1402 and may bedisposed of properly, and inserter 1400 is ready to be used again.Communication electronics (not shown) are then attached to mounting base1408, making electrical contact with sensor hub 1437.

A further embodiment of an inserter is illustrated in FIG. 52 . Inserter1500 is substantially identical to inserters 900, 1000, 1100B, 1200,1300, and 1400 described herein, with the substantial differences notedherein and illustrated in the accompanying figures.

Inserter 1500 includes a housing 1502, which may be fabricated as amolded plastic tube and may further include a living hinge cap 1504. Insome embodiments, a living hinge is a thin flexible plastic junctionthat connects two mating parts. The hinge keeps the parts attached andmay be folded completely without failure to allow the two parts to fullymate.

Cap 1504 may be further provided with a cutout portion to provide accessto the index finger and restrict the insertion motion along a desiredaxis. Cap 1504 is closed up and bonded to the housing through chemicalor ultrasonic bonding after the bellow-button assembly (describedherein) is provided.

Inserter further includes bellows 1506, which, in some embodiments, isconstructed from molded thin wall plastic with an integrated compressionspring which collapses during the insertion action, and which providesthe force to retract sharp 1524 after insertion. Bellows 1506 also hidessharp 1524 from exposure. The top portion 1520 of the bellows 1506 issecured to button 1514, and bottom portion 1521 is secured to housing1502.

A button 1514 provides the capability of the user to insert on bodyhousing 122 into the skin of the subject. Button 1514 may be fabricatedfrom plastic and may further include anti-rotation features, e.g.,recess 1515 which glides along longitudinal ridge 1517, restrictingmotion to the desired longitudinal axis. Needle hub 1536 is glued ordirectly molded onto button 1514. Sharp 1524 is securely held on to onbody housing 122, as described herein (See, e.g., FIGS. 11-13 ).

An adhesive patch 1518 secures on body housing 122 to the skin of thesubject. In some embodiments, the adhesive patch 1518 includes ahigh-tack (i.e., high strength adhesive) region for contact with theskin. A protective liner is provided for removal prior to insertion. Onthe side of the adhesive patch facing inserter 1500, low-tack region1530 is provided on the periphery of the patch to allow easy removal ofhousing 1502 after insertion is completed. A high-tack region 1532 isprovided in the center portion of the patch to secure on body housing122 in place.

Referring to FIGS. 53-55 , inserter kit 1600 is illustrated withinserter 2310 and an adhesive mount 2312 removably attached to thebottom thereof. Inserter kit 1600 is further described in U.S. Pat. No.7,381,184, which is incorporated by reference herein for all purposes.

After preparing an insertion site on the skin, typically in theabdominal region, the user removes a liner (not shown) from adhesivemount 2312 to expose the bottom surface and a portion of the top surfaceof an adhesive tape 2320 located beneath mount 2312. Mount 2312, withinserter 2310 attached, is then applied to the subject's skin at theinsertion site. Actuator button 2324 is depressed, causing inserter 2310to fire, thereby inserting sensor 2314 into the subject's skin with apredetermined velocity and force. Once sensor 2314 has been insertedinto the skin, the patient removes inserter 2310 from mount 2312 bypressing release tabs (not shown) on opposite sides of inserter 2310 andlifting inserter 2310 away from mount 2312.

Once inserter 2310 is removed from mount 2312, communicationselectronics (not shown) can be slid into place. The circuitry of thecommunications electronics device makes electrical contact with thecontact pads on sensor 2314 after the communications electronics isfully seated on mount 2312. Once initialization and synchronizationprocedures are completed, electrochemical measurements from sensor 2314can be sent wirelessly from the communications electronics to a receiverunit.

In some embodiments, inserter kit 1600 is assembled from the followingcomponents: housing 2334, actuator button 2324, drive spring 2336,shuttle 2338, introducer sharp 2340, sensor 2314, retraction spring2342, inserter base 2344, upper liner (not shown), adhesive mount 2312,adhesive tape 2320, and lower liner (not shown).

Shuttle 2338 is slidably and non-rotatably constrained on base 2344 byarcuate guides 2360. Shuttle 2338 is generally formed by an outer ring2362 and an inner cup-shaped post 2364 connected by two bridges 2366.Bridges 2366 slide between the two slots (not shown) formed betweenguides 2360 and allow shuttle 2338 to travel along guides 2360 withoutrotating. Retraction spring 2342 is captivated at its outercircumference by guides 2360, at its bottom by the floor 2370 of base2344, at its top by bridges 2366, and at its inner circumference by theouter surface of shuttle post 2364. Drive spring 2336 is captivated atits bottom and outer circumference by the inside surface of shuttle post2364, at its top by the ceiling 2372 inside actuator button 2324, and atits inner circumference by stem 2374 depending from ceiling 2372. Whendrive spring 2336 is compressed between actuator button 2324 and shuttle2338 it urges shuttle 2338 towards base 2344. When retraction spring2342 is compressed between shuttle 2338 and base 2344, it urges shuttle2338 towards actuator button 2324.

Retraction spring 2342 will return shuttle 2338 to the neutral positionas shown after firing, but without sensor 2314 which remains inserted insubject's skin. Drive spring 2336 is preferably designed to be stifferthan retraction spring 2342 so that shuttle 2338 oscillations arequickly dampened out, and so introducer sharp 2340 does not return tosensor 2314 or the patient to cause injury. With sensor 2314 inserted inthe subject's skin, inserter 2310 can be removed from mount 2312 andthen lifting inserter 2310 away from mount 2312. Introducer sharp 2340remains protected inside housing 2334 during disposal of inserter 2310.Communications electronics can now be slid into place on mount 2312 aspreviously described.

In some embodiments, a proximal portion of stem 2374 is enlarged tocreate an interference fit with the coils of spring 2336. For example,one or more laterally extending ribs 2610 are added to stem 2374. Theinterference fit between ribs 2610 and spring 2336 is typically providedat the proximal (top) coils of spring 2336.

The diameter of the coils of spring 2336 increases slightly whencompressed and decreases slightly when extended. Ribs 2610 on stem 2374provide greatest interference when spring 2336 is extended. Theinterference fit provides increased stability of shuttle 2338 duringinsertion. In some embodiments, the interference fit prevents orminimizes distal movement of spring 2336, which may cause impact ofspring 2336 against shuttle 2338 and the end of the distal travel ofthese components.

Referring to FIGS. 56-70 , in another exemplary embodiment, inserter2600 generally includes: actuator button 2602 (FIG. 57 ), shuttle 2604(FIG. 58 ), inserter sharp 2610 with skin piercing edge 2612 (FIG. 58 ),retraction spring 2608 (FIG. 59 ), sensor 2614 (FIG. 60 ), housing 2616(FIG. 61 ), and base 2618 (FIG. 62 ). It is understood that inserter2600 may include additional or fewer components than described herein.Inserter 2600 is substantially identical to inserter 1600 describedherein, with the substantial differences noted herein and illustrated inthe accompanying figures. The assembly of the different components ofinserter 2600 is depicted in FIGS. 63-65 . As shown in FIG. 63 ,actuator button is adapted to be slidably inserted through an opening inshuttle 2604 where it locks into position. Further, as shown in FIG. 64, retraction spring 2608 is adapted to be inserted into a second openingon the opposite side of shuttle 2604. Additionally, in this view, sensor2614 has been attached to inserter sharp 2610. As shown in FIG. 60 ,sensor 2614 incorporates a biasing arm 2615 that positively seats thesensor 2614 into the inserter sharp 2610. This allows the inserter sharp2610 and sensor insertion portion 30 to be smaller, reducing the traumaand pain to the subject. Any number of the aforementioned sensorconnection methods can be utilized in conjunction with inserter 2600.For example, inserter sharp 2610 may be provided with rails and dimples,as previously described, in order to retain sensor 2614, the sharp 2610having a diameter of about 20 to about 26 gauge, e.g., 21 gauge to about25 gauge, where in certain embodiments the sharp is 21 gauge or 23 gaugeor 25 gauge. Such sharp may be used with a sensor having a width ordiameter—at least the portion that is carried by the sharp—of about 0.20mm to about 0.80 mm, e.g., about 0.25 mm to about 0.60 mm, where in someembodiments the width or diameter of at least a portion of a sensor is0.27 mm or 0.33 mm or 0.58 mm.

FIG. 66 depicts a cross-sectional view of the assemblage of FIG. 65after inserter 2600 has been fully assembled (joining housing 2616 tobase 2618). As depicted, retraction spring 2608 is surrounded by guides2622 on its sides and by shuttle 2604 and base 2618 when inserter 2600is assembled. Additionally, shuttle 2604 is adapted to slidably move onrails (not shown) within base 2618, thereby allowing it to move in alinear direction when actuator button 2602 is depressed. FIG. 66 depictsthe actuator button 2602 locked onto the shuttle 2604 using the first oftwo detent grooves 2607. In this configuration, the shuttle 2604 andactuator button 2602 are in a locked state relative to the housing 2616and base 2618, preventing accidental deployment of the shuttle duringshipping and handling. This configuration also allows for significantlysmaller packaging, resulting in lower shipping costs and improved bulkprocess efficiencies such as sterilization. FIG. 67 depicts the actuatorbutton 2602 locked onto the shuttle 2604 using the second of two detentgrooves 2607. In this configuration, the shuttle is ready to bedeployed. The actuator button 2602 is moved to the second detent groove2607 by a user pulling axially on the actuator button 2602 and housing2616.

FIGS. 68-70 illustrate the steps utilized to deploy sensor 2614 usinginserter 2600. FIG. 68 depicts inserter 2600 in a first configuration.The upward force exerted by retraction spring 2608 on shuttle 2604 (andconsequently actuator button 2602) keeps inserter 2600 in its cockedposition in the first configuration. As actuator button 2602 is pressedby a user against the bias of retraction spring 2608, it exerts adownward force on shuttle 2604 and retraction spring 2608. Introducersharp 2610, on which sensor 2614 is mounted, is consequently drivendownward and into the skin of the subject (e.g., to a secondconfiguration). Skin piercing edge 2612 pierces the skin of the subjectand allows sensor 2614 to be properly inserted, as shown in FIG. 69 .

As the force is removed from actuator button 2602, retraction spring2608 exerts an upward force on shuttle 2604, thereby causing introducersharp 2610 to return proximally to its original position inside ofhousing 2616 (e.g., to the first configuration). Sensor 2614 remainsimplanted in the patient's skin, as shown in FIG. 70 . In this position,the plunger is bent approximately 90 degrees by the user, which preventsfurther use of the device, and provides obvious visual and tactileindications that the device is used and ready to be disposed.

In another aspect of the disclosed subject matter, an inserter assembly,as illustrated in FIG. 71 , is provided which is useful for installing amedical device, such as an analyte sensor, in the skin of a subject.Inserter assembly 4300 may include an inserter, a medical device, suchas an analyte sensor, and a mount for positioning the medical device atleast partially in or on the skin of the subject. In some embodiments,the mount is a support structure, plate and/or member which is attached,adhered, or otherwise secured to the skin of the subject. The mount maybe applied to the skin of the subject simultaneously with the medicaldevice by the inserter. In other embodiments, the mount is installedafter or before installation of the medical device. A mount may beapplied by the inserter or separately. The mount may include features orstructures (e.g., adhesive, guides, barbs, tabs, etc.) to maintain thesensor in position with respect to the skin after insertion and/ormaintain the sensor in relative position with respect to the sensorcontrol unit.

Inserter assembly 4300 is useful for analyte measurement systems, e.g.,glucose measurement systems which include an on-body unit that may beassembled on the skin of the subject. For example, the on-body unit mayinclude a sensor and a sensor control unit. The sensor is typicallyinstalled in the patient. Subsequently, the sensor control unit isinstalled and coupled to the sensor. In other embodiments, the sensorcontrol unit is installed at the patient first, followed by installationof the sensor, which is then coupled to the sensor control unit. In yetother embodiments, the sensor and sensor control unit are simultaneouslyinstalled and coupled. An optional mount may or may not be used toposition the sensor and/or the sensor control unit.

Generally, the inserter assembly 4300 is useful to install a sensor inthe skin of a subject. A sensor (not shown) may be preloaded withininserter 4310 prior to installation. After preparing an insertion siteon the skin of a subject, the user removes an upper liner 4316 and lowerliner 4318 from mount 4312 to expose the bottom surface and a portion ofthe top surface of an adhesive tape located on the bottom surface of themount 4312. Mount 4312, with inserter 4310 attached, is then applied tothe subject's skin at the insertion site. In some embodiments, the mount4312 is first attached, and then the inserter is coupled to orpositioned within and/or adjacent to the mount 4312. The inserterincludes an actuator button 4324 (see FIG. 74 ) to be depressed causinginserter 4310 to fire, thereby inserting a sensor into the user's skin.As will be described herein, certain embodiments install the sensor witha predetermined velocity and force upon actuation. In some embodimentsof the disclosed subject matter, the inserter includes a safety memberto impede actuation of the inserter as described below.

In some embodiments, the sensor 4314 remains positioned at the mount4312 by one or more positioning techniques. For example, as illustratedin FIG. 72 , sensor 4314 has a surface 4356 that extends orthogonallyfrom main surface 4346. Surface 4356 may include an adhesive portionthat contacts the subject's skin 4328 or the mount 4312. In someembodiments, the raised end stop 4444 of mount 4312 is provided with araised bead or bump which is received in an aperture in sensor 4314.Following insertion of the sensor 4314 into the skin, the user mayremove the inserter 4310 from mount 4312, e.g., by pressing release tabs4326 on opposite sides of inserter 4310 and lifting inserter 4310 awayfrom mount 4312. In some embodiments, the inserter 4310 is retained byother techniques, e.g., a friction-fit or a snap-fit with the mount4312.

Once inserter 4310 is removed from mount 4312, a sensor control unit4330 can be positioned into place with respect to the mount 4312. Thecircuitry of sensor control unit 4330 makes electrical contact with thecontacts on sensor 4314 after sensor control unit 4330 is seated onmount 4312. For example, as shown in FIG. 72 , seal has an exterior wallfor surrounding electrical contacts on sensor 4314 (not shown in FIG. 72), and interior walls for isolating electrical contacts from each other.In some embodiments, rails on sensor control unit 4330 are slidablewithin corresponding rails or grooves 4434 on mount 4312.

In some embodiments, initialization and synchronization procedures arecompleted, and then electrochemical measurements from sensor 4314 can beprovided from sensor control unit 4330 to a monitor unit, such as, e.g.,portable monitor unit 4332, shown in FIG. 73 . Sensor control unit 4330and monitor unit 4332 communicate via connection 20 (in this embodiment,a wireless radio frequency (RF) connection). Communication may occur,e.g., via RF communication, infrared communication, Bluetooth®communication, Zigbee® communication, 802.1x communication, or WiFicommunication, etc. In some embodiments, the communication may include aradio frequency of 433 MHz, 13.56 MHz, or the like. In some embodiments,communication between sensor control unit 4330 and monitor unit 4332 mayinclude radio frequency identification (RFID) techniques, and may beactive RFID or passive RFID, where, in some embodiments, passive RFIDtechnology and the respective system components include the necessarycomponents therefor. For example, in one embodiment, the monitor unitmay include a backscatter RFID reader configured to transmit an RF fieldsuch that when the sensor control unit is within the transmitted RFfield, an antenna is tuned and in turn provides a reflected or responsesignal (for example, a backscatter signal) to the monitor unit. Thereflected or response signal may include sampled analyte level data fromthe analyte sensor. Additional exemplary details for various embodimentscan be found in, e.g., U.S. patent application Ser. No. 12/698,124 filedFeb. 1, 2010, the disclosure of which is incorporated by referenceherein for all purposes.

Sensor 4314, mount 4312 and sensor control unit 4330 can remain in placeon the subject for a predetermined maximum period of time that mayinclude hours, days, weeks, or a month or more. These components arethen removed so that sensor 4314 and mount 4312 can be properlydiscarded in some embodiments. The entire procedure above can then berepeated with a new inserter 4310, sensor 4314 and mount 4312, reusingsensor control unit 4330 and monitor unit 4332. In other embodiments,inserter 4310 is reusable.

Referring to FIG. 74 , the inserter assembly 4300 according to oneembodiment can be assembled as shown from the following components:housing 4334, actuator button 4324, drive spring 4336, shuttle 4338,introducer sharp 4340, sensor 4314, retraction spring 4342, inserterbase 4344, upper liner 4316, adhesive mount 4312, adhesive tape 4320,and lower liner 4318.

In some embodiments, sensor main surface 4346 is slidably mountedbetween U-shaped rails 4348 of introducer sharp 4340. In addition to theholding members disposed on the introducer, as described above,retention techniques are provided in certain embodiments to retain thesensor 4314 in position on sharp 4340 during storage of the inserter4300 and/or during insertion of the sensor 4314 into the subject's skin.For example, a sensor dimple (not shown) is provided which engages anintroducer dimple (also not shown). Introducer sharp 4340 can be mountedto face 4354 of shuttle 4338, such as with adhesive, heat stake orultrasonic weld.

In some embodiments, shuttle 4338 can be slidably and non-rotatablyconstrained on base 4344 by arcuate guides 4360. The shuttle can begenerally formed by an outer ring 4362 and an inner cup-shaped post 4364connected by two bridges 4366. Bridges 4366 can be configured to slidebetween the two slots 4368 formed between guides 4360 and allow shuttle4338 to travel along guides 4360 without rotating. In some embodiments,a retraction spring 4342 is provided, which can be captivated at itsouter circumference by guides 4360, at its bottom by the floor 4370 (seeFIG. 75 ) of base 4344, at its top by bridges 4366, and at its innercircumference by the outer surface of shuttle post 4364. In someembodiments, a drive spring is provided for advancing the sensor 4314and the sharp 4340 into the skin of the subject. For example, drivespring 4336 is captivated at its bottom and outer circumference by theinside surface of shuttle post 4364, at its top by the ceiling 4372 (seeFIG. 75 ) inside actuator button 4324, and at its inner circumference bystem 4374 depending from ceiling 4372. In some embodiments, a drivespring is omitted from the inserter assembly. In such case, for example,sensor 4314 and sharp 4340 are distally advanced by manual force appliedby a user.

When drive spring 4336 is compressed between actuator button 4324 andshuttle 4338 it can urge shuttle 4338 towards base 4344. When retractionspring 4342 is compressed between shuttle 4338 and base 4344, it urgesshuttle 4338 towards actuator button 4324.

When sensor 4314, introducer sharp 4340, shuttle 4338, retraction spring4342, drive spring 4336 and actuator button 4324 are assembled betweenbase 4344 and housing 4334 as shown in FIGS. 74-75 and described above,housing 4334 is snapped into place on base 4344. Base 4344 is held ontohousing 4334 by upper base barbs 4390 that engage upper openings 4392 inhousing 4334, and lower base barbs that engage lower openings in housing4334. Further details regarding the construction and operation ofinserter 4300 is provided in U.S. Pat. No. 7,381,184 which isincorporated by reference herein in its entirety for all purposes.

In some embodiments, retention techniques and/or structures are providedto assist in supporting the sensor 4314 with respect to the sharp 4340during storage and insertion. As illustrated in FIGS. 76-90 , retentionmechanisms are provided which are located on the sensor and/or thesharp.

FIGS. 76-77 illustrate a sensor 4514 which is provided with one or twolaterally extending tabs 4560. Tabs 4560 engage the rails 4548 of thesharp 4540 for retention. In some embodiments, a radiused edge on theears allow them to be formed in two punch operations, e.g., a hole punchand a straight cut. A gap between left hard-stop 4549 and the top ofsensor 4514 produces, during firing, a moment that biases the sensor tipinto the sharp channel. During deployment, the sensor deflects todisengage the sharp.

FIGS. 78-79 illustrate an inserter having a sensor retention mechanismin accordance with a further embodiment of the subject disclosure. Sharp4640 is provided with a clip 4660 that engages a retention window 4662at the top of sensor 4614 to provide retention of sensor 4614 in sharp4640, and vertical registration. Two drive blocks 4659 and 4661 oncarrier 4654 traverse sharp 4640 to engage the top edge of sensor 4614.There is a gap between the left drive block 4659 and the top edge ofsensor 4614. Right drive block 4661 is in contact with the top edge ofsensor 4614. During insertion, the upward drive force of the skin onsensor 4614 produces a clock-wise rotational moment on sensor 4614 thatbiases sharp 4614 into the sharp channel.

The clip feature 4660 and the window 4662 can be moved to the left tobias the tip of the sensor 4614 into the channel during shipping. Duringdeployment, the sensor 4614 and the clip 4662 deflect to transfer thesensor 4614 to the mount 4312.

FIG. 80 illustrates a further embodiment of a sensor retentiontechnique. In particular, sensor 4714 is provided with a retentionmember 4760, which extends from the contact portion 4732 of the sensor4714. Retention member 4760 is resiliently biased in the position asshown. When the sensor 4714 is inserted within the sharp (not shown),the retention member engages the inner portion of rails (not shown) ofthe sharp, and provides a retention force to the sensor 4714.

FIG. 81 illustrates another embodiment of a sensor retention technique.Sensor 4814 is provided with a dimple 4860 which is thermally formed. Asshown in FIG. 82 , a raised bump 4864 on the sharp 4840 frictionallycontacts thermally formed dimple 4860 in order to provide retentionforce to the sensor 4814. In some embodiments, raised bump is formedusing heat. In another embodiment, a raised bump is formed on the sensorand the dimple is formed on the sharp.

FIGS. 83-84 illustrate an aperture 4960 which is formed in the contactportion of the sensor 4914. A raised bump or tab 4962 is provided on thesharp 4940. The interaction of the tab 4962 within the aperture 4960 ofthe sensor 4914 assists in retaining the sensor 4914 within theinserter.

FIGS. 85-86 illustrate a technique for retention of the sensor 5014which is similar to the techniques illustrated in FIGS. 81-84 . Forexample, a raised bump 5062 is provided on sharp 5040 which engages thecontact portion 5032 of the sensor 5014. In such configuration, theraised bump 5062 creates a bias force against the contact portion 5032.Such force acts as a frictional force to assist retention of the sensor5014 within the sharp 5040.

FIGS. 87 and 88 illustrate sensors having retention members which engagea raised post or button on the sharp. FIG. 87 illustrates that contactportion 5132 of sensor 5114 includes a pair of “pincer fingers” 5160having a substantially arcuate configuration which surround and engage apost 5162 provided on the sharp. Similarly, FIG. 88 illustrates sensor5214 having a pair of proximally extending arms 5260, which engage apost 5262 on the sharp.

FIG. 89 illustrates a sensor 5314 having a laterally extending arm 5360which defines a channel 5364 between the arm 5360 and the contactportion 5332 of the sensor 5314. As illustrated in the figure, a post5360 may be positioned within the channel 5364, and provides frictionalresistance to maintain the sensor 5314 within the sharp.

FIG. 90 illustrates a sensor 5414 having a proximally extending arm 5460which defines a channel 5362 between the arm 5460 and the contactportion 5432 of the sensor 5414. As illustrated in the figure, a tab5364 is provided on the arm 5460 and is received within a gap providedin the rails of the sharp. This interaction of the tab 5364 with the gapprovides frictional resistance to maintain the sensor 5414 within thesharp.

FIGS. 91-92 refer to sensor retention techniques which include aretention member which provides a frictional force substantially normal(perpendicular) to the surface of the sensor. FIGS. 91 and 92 illustratea retention member which is provided within the housing 5534 of theinserter 5510. For example, the retention member 5560 may extenddistally from the housing 5534 and includes a laterally extending tab5562 which contacts the sensor 5563 and provides a frictional force toassist retention of the sensor within the sharp 5540.

FIGS. 93 and 94 illustrate a retention member which is provided with thebase 5644 of the inserter 5610. For example, retention member mayinclude a cantilever 5660 which extends proximally from base 5644 of theinserter 5610. Cantilever 5660 may include a laterally extending member5662 which contacts the sensor 5661 and provides a frictional force toassist retention of the sensor within the sharp 5640. When the carrier5666 bottoms down, the cantilever 5660 ceases contact, and release ofthe sensor occurs.

FIGS. 95 and 96 illustrate a resilient or elastomeric member which isdisposed within the housing 5734 of the inserter 5710. For example,elastomeric member 5760 is manufactured from TPE and presses against thesensor and the resulting friction keeps the sensor in place. The TPEmaterial creates a higher friction with respect to the sensor, andtherefore requires less pressure to produce the sensor holding force.When the inserter 5710 is actuated, the frictional forces are directedupward keeping the sensor inside the sharp. When the carrier bottomsdown, the contact with the friction rib ceases and the sensor releasesto the mount. In some embodiments, the elastomeric member 5760, or rib,is produced with a second-shot injection molded process or press-fitinto housing 5734.

FIGS. 97 and 98 refer to retention members which provide a frictionalforce in a substantially coplanar direction to the surface of thesensor. FIG. 97 illustrates a retention member or cantilever 5860 whichis biased against the side edge of the contact portion 5832 of thesensor 5814. In some embodiments, cantilever 5860 is provided on thecarrier or sharp (not shown). FIG. 98 illustrates a sensor retentiontechnique which includes a retention member, or cantilever 5960 which isbiased against the sensor, as described in FIG. 97 . Cantilever 5960includes a laterally extending portion which is at least partiallyreceived in an optionally provided notch 5964 in sensor 5914. Inaddition, a second retention member, or retention spring 5990, isprovided which is biased to engage the front surface of the sensor. Insome embodiments, retention spring 5990 is partially received in cut-out5994 (or a slot) to capture the sensor.

In some embodiments, an inserter assembly is provided which includes areusable inserter apparatus. Repeated uses of the inserter include theuse of a removable and exchangeable sensor and sharp which may becoupled to the inserter during deployment of the sensor, and in whichthe sharp is removed and discarded after deployment.

FIGS. 99-101 illustrate a system of sharp/sensor packs 6002 whichcontain a plurality of sensor/sharp combinations 6006. As illustrated inFIGS. 99 and 101 , a support is provided which includes a plurality oftrays 6004 which are useful for containing the sensor/sharpconfiguration 6006, and well as a desiccant 6010 which is contained in achamber 6008. A well 6012 is provided on one side of the tray 6004 toaccommodate the sensor sharp for installation into a patient. A cover,such as a foil lid 6014 is applied to the top of the support to maintainthe sterility of the sensor/sharp combination until installation in asubject. FIG. 100 is a perspective view which illustrates an exemplaryconfiguration of pack 6002. The foil lid 6014 for each of trays 6004 mayinclude a tab 6016 to facilitate removal of the lid from the tray 6004(FIGS. 100, 101 ).

FIGS. 102-105 illustrate a plurality of reusable inserters which areuseful in combination with the sharp/sensor packs 6002 described herein.FIG. 102 illustrates an inserter 6030 which includes a body portion6032, a loading or cocking structure 6036, and an actuator button 6040for deploying the sensor into the skin of the subject. The advancementstructure of inserter 6030 may include a cocking structure which ispulled to arm, e.g., by withdrawing the cocking structure 6036 from thehousing 6032; which is pushed to arm, e.g., by depressing the cockingstructure 6036 into the housing 6032; or which is rotated to arm, e.g.,by rotating the cocking structure 6036 in a rotational movement parallelto the longitudinal axis of the inserter 6030, or perpendicular to thelongitudinal axis of the inserter 6030. The driving mechanism ofinserter 6030 is substantially similar to the driving mechanisms asdisclosed in U.S. Patent Publication 2008/0082166, now U.S. Pat. No.8,167,934, 6,197,040, or 4,976,724, which are incorporated by referencein their entirety herein for all purposes.

To insert the sharp/sensor combination into the inserter 6030, the foillid is removed from sharp/sensor pack 6002. The distal end portion 6034of the inserter 6030 is positioned within the walls 6004 of the tray6002, as indicated in the direction of arrow E. The distal end portion6034 comes to rest on the upper surface of desiccant chamber 6008, suchthat the insertion sharp remains exposed.

FIG. 103 illustrates an inserter 6130 substantially identical to theinserter 6030 described herein. Inserter 6130 is used in connection withsharp/sensor trays 6102. Trays 6102 include a desiccant chamber 6108which is located in the center portion of the tray 6102. Accordingly, achannel 6112 surrounds the periphery of desiccant chamber 6108. When theinserter 6130 is applied to the sharp/sensor tray 6102, the distal endportion 6134 can be positioned within the channel 6112. As illustratedin FIG. 103 , this configuration allows the sensor and sharp to becompletely housed within the inserter 6130.

FIG. 104 illustrates an inserter 6230 substantially identical to theinserters 6030 and 6130 described herein, with the differences notedherein and illustrated in the figures. Inserter 6230 may be used inconnection with sharp/sensor trays 6204. The tray 6204 and inserter 6230are sized and configured such that tray 6204 is capable of beingpositioned entirely within the distal end portion 6234 of inserter 6230.One or more support struts 6220 are provided adjacent the distal endportion 6234 to stabilize the inserter with respect to any surface onwhich the inserter 6230 and trays 6204 are placed for the insertionstep. Support struts 6220 may also secure inserter 6230 to an adhesivemount (not shown) during insertion.

FIG. 105 illustrates an inserter 6330 which is substantially identicalto the inserters 6030, 6130, and 6230 described herein, with thedifferences noted herein and illustrated in the figures. Inserter 6330may be used in connection with sharp/sensor tray 6304. In someembodiment, tray 6304 includes a distally projecting handle portion 6340which may be grasped by the user to facilitate insertion of thesharp/sensor into the inserter.

FIGS. 106-107 illustrate an exemplary sharp/sensor combination for usewith inserters 6030, 6130, 6230, and 6330 described herein. Sharp 6440includes side rails 6448 for sliding reception of a sensor therein. Alocking tab 6450 is also provided on the proximal portion of the sharpand includes cut-out portion 6452 for interlocking with the carrier ofthe inserter 6030 (or 6130, 6230, or 6330). As illustrated in FIGS.108-112 carrier 6466 includes reception structure for mating receptionwith the sharp 6440. For example, carrier 6466 may include a pair ofwalls 6480 providing a channel 6478 in which said sharp 6440 may bepositioned. Walls 6480 are provided with cutout portions 6482 forreception of undercut portion 6452 in locking tab 6450. A pair ofsecurement members 6484 are movably mounted on the carrier 6466. Forexample, members 6484 are biased via a spring 6486 towards a centerportion of the carrier 6466. As illustrated in FIG. 111 , securementmembers 6484 may be moved outwardly against the spring bias to allow forthe insertion of the locking tab 6450 into the cutout portion 6482 ofthe carrier. Securement member 6484 is subsequently released and returnsto a position to engage the undercut portion 6452 to prevent accidentalremoval of the sharp and sensor from the inserter (FIG. 112 ). It isunderstood that coupling of the sharp and carrier may be provided byalternative techniques such as frictional fit, snap-fit, bayonet mounts,magnetic coupling, etc.

FIGS. 113-117 illustrate a further embodiment of the subject disclosurethat is reusable, and useful with the sharp/sensor packs discussedherein. FIG. 113 illustrates a sensor pack 6504 which is similar to thesensor packs described herein. Sharp/sensor pack 6504 also includes oneor more reinforcing ribs 6574 to prevent accidental deformation of thepack 6504 when the sensor is being inserted into the inserter.

As illustrated in FIG. 114 , inserter 6530 is provided which issubstantially similar to inserters 6030, 6130, 6230, and 6330 describedherein, with the differences noted herein or illustrated in the figures.Inserter 6530 includes a carrier (not shown) for coupling with asharp/sensor combination. As illustrated in the figure, inserter 6530 islowered onto sharp/sensor pack 6504 in order to couple the sharp 6506with the carrier. As illustrated in FIG. 115 , inserter 6530 which nowcontains the sharp/sensor 6506 is positioned over the mount 6512. Mount6512 may include an adhesive for securement to the skin of the subject.Inserter 6530 includes a locking structure 6526 which allows fortemporary engagement of the inserter 6530 with the mount 6512.

As illustrated in FIG. 116 , the sensor is deployed by depressingactuation button 6532 on the inserter 6530 to advance the sensor intothe skin by use of an internal drive mechanism, such as, e.g., a spring.It is understood that the above-described process may alternatively becarried out by using an inserter which allows the user to provide amanual distal force for deployment of the sensor.

Following installation of the sensor, inserter 6530 is decoupled fromthe mount, e.g., by depressing locking buttons 6526 on inserter 6530.Once the inserter 6530 is separated from the mount, the user may removeand discard the sharp. In some embodiments, inserter 6530 includes asliding lever 6540 which allows for removal of the sharp. It isunderstood that disengagement of the sharp from carrier may be executedin one of several ways, e.g., sliding switch allows securement member(discussed herein) to slide outwardly and allow disengagement of thecontact portions 6483 of the securement members 6484 from the undercutportions 6452 of locking tab 6450.

FIG. 118 illustrates an inserter 6630 and engagement structure formounting on mount 6612. Inserter 6630 includes a body portion 6640 whichis configured to advance a sharp/sensor cartridge into the skin S of asubject along longitudinal axis LON. The longitudinal axis LON may besubstantially perpendicular to the skin surface. In some embodiments,axis LON forms an acute angle with the skin surface. Mount 6612 andinserter 6630 are each provided with complementary locking structures6662 on the mount 6612 and 6664 on the inserter. Inserter is advancedlaterally (direction LAT) over mount 6612. Inserter 6630 may be lockedin place by pivoting locking structure 6632 about pivot 6626. Followingsuch pivoting action, the engagement portion 6666 of locking structure6632 is received in recess 6668 in mount 6612. Securement of theinserter to the mount is further provided by insertion of thesharp/sensor cartridge 6650 between the inserter 6630 and the mount6612. For example, cartridge 6650 includes raised tabs 6654 which areslidable within complementary grooves 6652 provided on the inserter 6630and mount 6612. Insertion of the cartridge is carried out in a directionperpendicular to the direction in which the inserter is attached to themount, e.g., a direction perpendicular to the plane of the page.

FIGS. 119-121 illustrate another embodiment of an inserter in accordancewith the disclosed subject matter. Inserter 6730 is useful for advancinga medical device, such as an analyte sensor, into the skin of a subject.Inserter 6730 includes a hammer member 6760 which accumulatesadvancement energy to provide a more rapid and powerful advancementstroke. As illustrated in FIG. 119 , hammer member 6760 is initiallypositioned somewhat askew with respect to the longitudinal axis of thedevice. As the alignment trigger 6734 is advanced distally, alignmentsleeves 6736 gradually pivot the hammer member 6760 into a longitudinalconfiguration. As the hammer member 6760 is being pivoted into position,the advancement spring continues to be compressed. With reference toFIG. 120 , the hammer member 6760 is pivoted into alignment with thecentral bore of the inserter 6730, e.g., along the longitudinal axisrepresented by the arrow. Consequently, the tension of advancementspring 6742 is immediately released, which permits rapid distal movementof the hammer member 6760. Hammer member 6760 contacts carrier 6744,which in turn contacts sharp/sensor combination 6718 to provide distalmovement.

As illustrated in FIG. 121 , a ledge or lateral member 6726 is providedwith the internal bore of the inserter. As the hammer member 6760advances distally, the distal surface of the hammer member contacts theledge 6726. Interengagement of the hammer member 6760 and the ledge 6726inhibits further distal travel of the hammer member 6760.

FIG. 122 illustrates an exemplary embodiment of a simplified unit, orcartridge 6800, which holds certain components for sterility andsubsequent interaction with the subject. In some embodiments, thecomponents include the sharp 6840, the housing 6860, the sensor 6814.The cartridge 6800 may be used in connection with any of the inserters6030, 6130, 6230, 6330, 6530 and/or 6730 described herein. In someembodiments, the cartridge includes a housing and a lid which containthe sharp and sensor therein. In some embodiments, a resilient member orother cantilever structure is used to maintain the alignment of thesharp and sensor within the cartridge. Interaction of the cartridge withthe inserter advances the sensor and sharp such that the sensor isinstalled at the subject.

As illustrated in FIGS. 123-124 , the sharp 6840 and sensor 6814 may sitin a recessed portion of the disposable cartridge 6800. A spring fingeror cantilever 6876 on the housing lid maintains a load on the sharp 6840and sensor 6814 to keep it depressed in the cavity. Attachment for a lidto the base of the cartridge housing 6860 is not shown in the figureabove, but methods such as snaps, heat stake, or ultrasonic welding maybe used to join the two housings in assembly. The sensor 6814 iscontained within the sharp 6840, laterally by the two rounded ends 6848of the sharp, and in the orthogonal lateral direction (in relation tothe views shown above), by two bent tabs 6849 on the sharp 6840 and thecartridge housing base cavity. The sharp is held in its lateral positionby not only the cavity, but also by the raised pyramid feature 6878shown on the housing base 6870. In the figure above, the locatingpyramid sits in the opening 6882 created from the bent tab in the sharp.The engagement features to locate/attach/engage the cartridge to theinserter portion of the device are not shown in the figures above, butmay include such features as illustrated in FIGS. 106-112 above.

As illustrated in FIGS. 125 and 126 , when the cartridge 6800 is loadedonto the reusable inserter part of the device, the sharp is raised outof its cavity by stationary elements built onto the inserter (notshown). Features from the reusable portion of the inserter enter throughthe two shorter slots shown FIG. 122 . These features will remainstationary throughout the sensor delivery action of the inserter device.

In the longer middle slot 6866, a stepped feature from the inserter,mates with the opening on the sharp (shown as two holes 6864 in thefigure above). The stepped portion of the feature provides a force onthe back portion of the sharp to keep it raised against the force of thesprung cantilever 6876 on the housing. This feature of the inserter willmove in relation to the cartridge and provide the drive and retractionmovement for the sharp through insertion and delivery of the sensor. Insome embodiments, the force is transmitted through driving pins whichare part of the movable portion of the inserter device. The driving pinsprotrude through holes 6864. In case of minor misalignment of thedriving pins (not shown), ribs on the cartridge housing lid willconstrain the sharp from tilting up.

Once the sharp and sensor are raised from the cavity portion of thecartridge, they are no longer constrained by the recessed cavity portionof the housing base and the pyramid feature maintaining the sharpposition. The sharp is held in its raised position by the stationary andstepped drive feature of the inserter, balanced with the force of thecantilever finger on the lid housing. The sensor is kept in place bybeing pinched against the cantilever finger on the housing lid. Thesharp is constrained in its retracted position by the mated drivefeature of the inserter.

As the inserter is actuated, the mated inserter drive feature drives thesharp downward as it moves through the longer slot shown in the figureabove (see FIGS. 127-129 ). The driven sharp slides along the stationaryribs of the inserter, ribbed features built into the cartridge housing,and the housing lid cantilever finger. The friction force of thecantilever keeps the sensor up against the ‘drive block’ and bends inthe sharp sheet metal to assure the tail is not exposed from the sharpchannel during insertion. In some embodiments, the ‘drive block’features are longitudinal constraints either built into the sharp or thecarrier which constrain the sensor from proximal movement with respectto the sharp. In another embodiment, the drive block features areprotrusions on the carrier or bends on the sharp which push the sensoras the sharp is propelled distally.

The sensor is kept from popping over the drive block features by thestationary ribs built into the housing lid. As the cantilever slidesover the top edge of the sensor, the retention force is relieved fromthe sensor, and it can be captured onto the mount portion of the devicewith relatively little force. Alternately, if geometry permits, and thefinger is positioned appropriately, the pinching of the cantilever onthe sharp may provide enough resistance on the return motion of thesharp to keep the sensor in its inserted position even without a capturedevice on the mount. The inserter drive feature then retracts the sharp,leaving the sensor in place on the mount portion (that is attached tothe skin) of the device.

The cartridge can be removed from the inserter. As the cartridge isremoved, the force from the housing lid cantilever presses the sharpback into the recess on the cartridge base housing. The base housing isremoved and can be discarded.

Another embodiment of the cartridge is illustrated in FIGS. 131-137 . Asillustrated in FIG. 131 , the sharp 6940 and sensor 6914 in thisembodiment abuts ribs 6972 and 6974 and on insertion plane to which thesharp 6940 will be driven and retracted by the inserter into the skin.The sharp and sensor are held in place by a central cantilever feature6976 built onto the cartridge lid housing. This cantilever 6976 hasgeometry such that a vertical portion of the end of the cantilever isbutted against the sharp 6940 and sensor 6914.

As illustrated in FIGS. 132 and 133 , the cartridge 6900 is loaded ontothe inserter, in which a stationary feature on the inserter (not shown)raises the cartridge cantilever so that the ramped portion of thecantilever end feature is now in line with the insertion plane of thesharp. Also, a driving element of the inserter (not shown) fits throughthe slot opening on the sharp. In the embodiment described herein, astep is not required on the driving element on this design.

As the sharp is driven downward (see, FIGS. 134-135 ), the cantileverarm 6976 is pushed up, keeping the sensor in position against the sharp6940. Stationary ribs on the housing lid assure that the sharp 6940maintains its insertion plane during insertion, and also assures thatthe pinching force of the cantilever does not cause the sensor to hopthe drive block elements integrated into the sharp. The stationary ribskeep the sensor flat against the sharp through the insertion motion.

As illustrated in FIGS. 136-137 , the sensor 6914 is captured at thebottom of its motion on the mount, as discussed hereinabove. The driveelements on the inserter retract the sharp 6940 back to its startingposition. The cantilever arm 6976 returns to its original unbiasedconfiguration. The cartridge 6900 is removed from the inserter and canbe discarded.

It is understood that the subject matter described herein is not limitedto particular embodiments described, as such may, of course, vary. It isalso understood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting, since the scope of the present subject matter is limited onlyby the appended claims.

1-10. (canceled)
 11. An inserter assembly for partially inserting aglucose sensor into a subject, the inserter assembly comprising: aninserter housing; a carrier coupled with a sharp, the sharp configuredto be inserted into a skin of the subject; the glucose sensor releasablycoupled with the sharp, the glucose sensor comprising: a distal portionconfigured to be positioned under the skin of the subject and in contactwith an interstitial fluid of the subject, and a proximal portionconfigured to be positioned above the skin and coupled with sensorelectronics; a retention member disposed within the inserter housing,wherein the retention member is a separate structure from the glucosesensor and the sharp; a drive spring configured to advance the carrier,the sharp, and the glucose sensor from a proximal position to a distalposition; and a retraction spring configured to retract the carrier andthe sharp from the distal position to a retracted position entirelywithin the inserter housing, and wherein the retention member isconfigured to retain a part of the glucose sensor within the sharp whilethe carrier, the sharp, and the glucose sensor are in the proximalposition by providing a force in a direction substantially perpendicularto a surface of the glucose sensor.
 12. The inserter assembly of claim11, wherein the retention member is an elastomeric member.
 13. Theinserter assembly of claim 11, wherein the force provided by theretention member is a frictional force.
 14. The inserter assembly ofclaim 11, wherein the retention member is further configured to retainthe part of the glucose sensor within the sharp during storage of theinserter assembly.
 15. The inserter assembly of claim 11, wherein theretention member is further configured to retain the part of the glucosesensor within the sharp during advancement of the glucose sensor and thesharp from the proximal position to the distal position.
 16. Theinserter assembly of claim 11, wherein the retention member is furtherconfigured such that the retention member does not provide the force tothe glucose sensor after the carrier, the sharp, and the glucose sensorreach the distal position.
 17. The inserter assembly of claim 11,wherein the retention member is further configured such that theretention member does not provide the force to the glucose sensor afterthe sharp releases the glucose sensor.
 18. The inserter assembly ofclaim 11, further comprising an actuator button configured to, upondepression, cause the drive spring to advance the carrier, the sharp,and the glucose sensor from the proximal position to the distalposition.
 19. The inserter assembly of claim 11, further comprising anadhesive layer configured for placement on the skin of the subject,wherein the adhesive layer comprises an aperture, and wherein the sharpand the glucose sensor are configured to extend through the aperturewhen the carrier, the sharp, and the glucose sensor are in the distalposition.
 20. The glucose monitoring system of claim 11, wherein theglucose sensor further comprises a bendable portion located between theproximal portion and the distal portion.
 21. The inserter assembly ofclaim 20, wherein the distal portion of the glucose sensor is in a firstplane, and wherein the proximal portion of the glucose sensor is in asecond plane that is substantially perpendicular to the first plane. 22.The inserter assembly of claim 11, wherein the glucose sensor isconfigured to have a predetermined monitoring time period of about tendays or more.
 23. The inserter assembly of claim 11, wherein the glucosesensor is configured to have a predetermined monitoring time period ofabout fourteen days or more.
 24. An inserter assembly for partiallyinserting a glucose sensor into a subject, the inserter assemblycomprising: an inserter housing; an actuator button; a carrier coupledwith a sharp, the sharp configured to be inserted into a skin of thesubject; the glucose sensor releasably coupled with the sharp, theglucose sensor comprising: a distal portion configured to be positionedunder the skin of the subject and in contact with an interstitial fluidof the subject, and a proximal portion configured to be positioned abovethe skin and coupled with sensor electronics; an elastomeric retentionmember disposed within the inserter housing, wherein the elastomericretention member is a separate structure from the glucose sensor and thesharp; a drive spring configured to, upon depression of the actuatorbutton, advance the carrier, the sharp, and the glucose sensor from aproximal position to a distal position; and a retraction springconfigured to retract the carrier and the sharp from the distal positionto a retracted position entirely within the inserter housing, andwherein the elastomeric retention member is configured to retain a partof the glucose sensor within the sharp while the carrier, the sharp, andthe glucose sensor are in the proximal position.
 25. The inserterassembly of claim 24, wherein the elastomeric retention member isfurther configured to provide a force in a direction substantiallyperpendicular to a surface of the glucose sensor while the carrier, thesharp, and the glucose sensor are in the proximal position.
 26. Theinserter assembly of claim 25, wherein the elastomeric retention memberis further configured such that the elastomeric retention member doesnot provide the force to the glucose sensor after the carrier, thesharp, and the glucose sensor reach the distal position.
 27. Theinserter assembly of claim 25, wherein the elastomeric retention memberis further configured such that the elastomeric retention member doesnot provide the force to the glucose sensor after the sharp releases theglucose sensor.
 28. The inserter assembly of claim 25, wherein the forceis a frictional force.
 29. The inserter assembly of claim 24, whereinthe elastomeric retention member is further configured to retain thepart of the glucose sensor within the sharp during storage of theinserter assembly.
 30. The inserter assembly of claim 24, wherein theelastomeric retention member is further configured to retain the part ofthe glucose sensor within the sharp during advancement of the glucosesensor and the sharp from the proximal position to the distal position.31. The inserter assembly of claim 11, further comprising an adhesivelayer configured for placement on the skin of the subject, wherein theadhesive layer comprises an aperture, and wherein the sharp and theglucose sensor are configured to extend through the aperture when thecarrier, the sharp, and the glucose sensor are in the distal position.32. The glucose monitoring system of claim 24, wherein the glucosesensor further comprises a bendable portion located between the proximalportion and the distal portion.
 33. The inserter assembly of claim 32,wherein the distal portion of the glucose sensor is in a first plane,and wherein the proximal portion of the glucose sensor is in a secondplane that is substantially perpendicular to the first plane.
 34. Theinserter assembly of claim 24, wherein the glucose sensor is configuredto have a predetermined monitoring time period of about ten days ormore.
 35. The inserter assembly of claim 24, wherein the glucose sensoris configured to have a predetermined monitoring time period of aboutfourteen days or more.